Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

Calendar

October 2021 training courses

Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

19-20 Oct 2021 - Online webinar

How to produce quality regulatory documents including the clinical evaluation report (CER)

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

View details

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations Training Course

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations

20 Oct 2021 - Online webinar

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

Presented by Rayyan Mughal (bio)
Simon Portman (bio)

View details

Filing eCTD Submissions Training Course

Filing eCTD Submissions

20 Oct 2021 - Online webinar

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

View details

EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

21-22 Oct 2021 - Online webinar

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.

The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

Presented by Norah Lightowler (bio)

View details

Patentability and State-of-the-Art Searching Training Course

Patentability and State-of-the-Art Searching

26-27 Oct 2021 - Online webinar

A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.

Presented by Stephen Adams (bio)
Jane List (bio)

View details

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

26-29 Oct 2021 - Online webinar

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

View details

Drafting Commercial Contracts Training Course

Drafting Commercial Contracts

27-28 Oct 2021 - Online webinar

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Presented by Mark Weston (bio)

View details

Dealing With Difficult People Training Course

Dealing With Difficult People

29 Oct 2021 - Online webinar

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is an interactive online course consisting of 2 x 90 minute modules.

Presented by Geoff Marsh (bio)

View details

November 2021 training courses

Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

1-2 Nov 2021 - Online webinar

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

View details

Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

1-2 Nov 2021 - Online webinar

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 3 more leading experts

View details

How to Improve Accuracy and Attention to Detail Training Course

How to Improve Accuracy and Attention to Detail

1 Nov 2021 - Online webinar

Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working

Presented by Laura Brown (bio)

View details

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

2-3 Nov 2021 - Online webinar

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)

View details

The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The New EU Animal Health Legislation for Veterinary Medicinal Products

2-3 Nov 2021 - Online webinar

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

Presented by Julian Braidwood (bio)

View details

How to Avoid Common Pitfalls in Combined EU (European Union)/US Patent Applications Training Course

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

3-4 Nov 2021 - Online webinar

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Presented by Bradley Hulbert (bio)
David Meldrum (bio)

View details

Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

5 Nov 2021 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)

View details

Influencing, Persuading and Negotiating Skills for International Lawyers Training Course

Influencing, Persuading and Negotiating Skills for International Lawyers

8-9 Nov 2021 - Online webinar

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Presented by Arun Singh OBE (bio)

View details

Advanced Drafting Techniques for Successful EPO (European Patent Office) Patent Applications Training Course

Advanced Drafting Techniques for Successful EPO Patent Applications

9 Nov 2021 - Online webinar

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

View details

The Role of the Senior HR Manager Training Course

The Role of the Senior HR Manager

9-10 Nov 2021 - London

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

Presented by Jocelyn Hughes (bio)

View details

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

10-12 Nov 2021 - Online webinar

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

View details

The Pharma Mini MBA Training Course

The Pharma Mini MBA

10-12 Nov 2021 - Online webinar

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

Presented by Leela Barham (bio)
Laura Brown (bio)
Oguz Ozden (bio)

View details

Clean Communication Training Course

Clean Communication

10 Nov 2021 - Online webinar

Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

View details

Ownership and Control of Intellectual Property Rights Training Course

Ownership and Control of Intellectual Property Rights

11 Nov 2021 - Online webinar

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

Presented by Mark Weston (bio)

View details

The Art of European Claim Drafting Training Course

The Art of European Claim Drafting

11-12 Nov 2021 - Online webinar

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Presented by Joeri Beetz (bio)
Leythem Wall (bio)

View details

Mental Resilience in a Home-working Environment Training Course

Mental Resilience in a Home-working Environment

11 Nov 2021 - Online webinar

This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

View details

Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

15-17 Nov 2021 - Online webinar

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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IP (Intellectual Property) Department Roadmap Training Course

IP Department Roadmap

15-18 Nov 2021 - Online webinar

This course provides a step-by-step, matrix-based methodology with a top-down and cross-functional approach to design an IP department roadmap

Presented by Arnaud Gasnier (bio)

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Developing High Performance HR Business Partner and Consulting Skills Training Course

Developing High Performance HR Business Partner and Consulting Skills

16-17 Nov 2021 - Online webinar

Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.

Presented by Katie Botten (bio)

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Drafting International Commercial Agreements in English Training Course

Drafting International Commercial Agreements in English

16-18 Nov 2021 - Online webinar

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Presented by Alan Simmons (bio)

View details

Positive Persuading and Influencing Skills for Pharma Professionals Training Course

Positive Persuading and Influencing Skills for Pharma Professionals

16-17 Nov 2021 - Online webinar

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

Presented by Robert Hersowitz (bio)

View details

Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

18-19 Nov 2021 - Online webinar

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Presented by Graeme Ladds (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

18-19 Nov 2021 - Online webinar

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

22 Nov 2021 - Online webinar

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Marloes van der Geer (bio)

View details

Drafting and Negotiating International Agency and Distribution Agreements Training Course

Drafting and Negotiating International Agency and Distribution Agreements

23-24 Nov 2021 - Online webinar

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*

Presented by Michala Meiselles (bio)

View details

Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

Drafting Commercial Contracts for the Pharmaceutical Industry

24-26 Nov 2021 - Online webinar

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Presented by James Agnew (bio)
and 15 more leading experts

View details

Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

24-25 Nov 2021 - Online webinar

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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The Patent Administrator Training Course

The Patent Administrator

24 Nov 2021 - Online webinar

This course will give you a comprehensive introduction to the role of the patent administrator

Presented by JoAnna Emery (bio)

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

24-25 Nov 2021 - Online webinar

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

View details

Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

24-25 Nov 2021 - Online webinar

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Presented by Salma Ismail (bio)
Makram Nehme (bio)

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The Role and Responsibilities of the Contracts Manager Training Course

The Role and Responsibilities of the Contracts Manager

25-26 Nov 2021 - Online webinar

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

Presented by Catherine Hurst (bio)

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Reviewing and Negotiating Technology Transfer and Licensing Agreements Training Course

Reviewing and Negotiating Technology Transfer and Licensing Agreements

25-26 Nov 2021 - Online webinar

Providing key legal and commercial skills essential to secure a successful agreement.

Presented by Michala Meiselles (bio)

View details

Effective Defence of EPO (European Patent Office) Patent Applications Training Course

Effective Defence of EPO Patent Applications

29 Nov 2021 - Online webinar

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

View details

December 2021 training courses

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

1-2 Dec 2021 - Online webinar

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

View details

Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

1-2 Dec 2021 - Online webinar

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Ray Munden (bio)
Allan Watkinson (bio)

View details

Common Technical Document Training Course

Common Technical Document

1-2 Dec 2021 - Online webinar

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Presented by Hans van Bruggen (bio)

View details

US Patent Practice Training Course

US Patent Practice

1-2 Dec 2021 - Online webinar

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Presented by Nicole Reifman (bio)
James Suggs (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

1-3 Dec 2021 - London

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

1 Dec 2021 - London

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

View details

Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

1-3 Dec 2021 - London

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Adrian Haines (bio)
and 6 more leading experts

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Business and Contract Law Training Course

Business and Contract Law

2-3 Dec 2021 - Online webinar

A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Presented by Arun Singh OBE (bio)

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A Regulatory Update on Animal Feed and Feed Additives in the EU (European Union), USA and China Training Course

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

2-3 Dec 2021 - Online webinar

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

Presented by Elinor McCartney (bio)
Kristi Smedley (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

2 Dec 2021 - Online webinar

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

3 Dec 2021 - Online webinar

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Presented by Laura Brown (bio)

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IP (Intellectual Property) Due Diligence & Freedom to Operate in Practice Training Course

IP Due Diligence & Freedom to Operate in Practice

3 Dec 2021 - Online webinar

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Presented by Tim May (bio)
and 3 more leading experts

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Pharmacovigilance Training Course

Pharmacovigilance

6-8 Dec 2021 - Online webinar

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Presented by Glyn Belcher (bio)
and 6 more leading experts

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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

6-7 Dec 2021 - Online webinar

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Presented by Julian Braidwood (bio)

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Managing stress & anxiety Training Course

Managing stress & anxiety

6 Dec 2021 - Online webinar

A 60-90 minute webinar exploring stress & anxiety.
14:00 UK

Presented by Louisa Elder (bio)
Ian White (bio)

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3-day Drafting Commercial Contracts Training Course

3-day Drafting Commercial Contracts

6-8 Dec 2021 - Online webinar

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Presented by Mark Weston (bio)

View details

Liabilities, Damages and other Contentious Issues in International Commercial Agreements Training Course

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

6-7 Dec 2021 - London

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Presented by Arun Singh OBE (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

8-9 Dec 2021 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Project Management for Pharma Professionals Training Course

Project Management for Pharma Professionals

9-10 Dec 2021 - Online webinar

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

Presented by Laura Brown (bio)

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

9-10 Dec 2021 - London

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

10 Dec 2021 - Online webinar

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

Presented by Brian Kelly (bio)
David Richardson (bio)
Penny Viner (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

13-17 Dec 2021 - Online webinar

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Janette Benaddi (bio)

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

14-15 Dec 2021 - Online webinar

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 6 more leading experts

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

15-16 Dec 2021 - Online webinar

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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January 2022 training courses

EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

10-11 Jan 2022 - London

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Presented by Laura Brown (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

11-12 Jan 2022 - London

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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Employment Law in Practice from Recruitment to Termination Training Course

Employment Law in Practice from Recruitment to Termination

11-12 Jan 2022 - London

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Presented by Toni Trevett (bio)

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Biosimilars Training Course

Biosimilars

11-12 Jan 2022 - London

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Marloes van der Geer (bio)

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Drafting Commercial Contracts Training Course

Drafting Commercial Contracts

11-12 Jan 2022 - London

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Presented by Mark Weston (bio)

View details

Dealing With Difficult People Training Course

Dealing With Difficult People

11 Jan 2022 - London

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is an interactive online course consisting of 2 x 90 minute modules.

Presented by Geoff Marsh (bio)

View details

A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

13 Jan 2022 - Online webinar

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

17-18 Jan 2022 - London

Optimising oversight for inspection compliance

Presented by Laura Brown (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

18 Jan 2022 - London

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

View details

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace Training Course

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

18 Jan 2022 - London

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

Presented by Toni Trevett (bio)

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A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

20 Jan 2022 - Online webinar

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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The Role and Skills of a Valuable HR Assistant Training Course

The Role and Skills of a Valuable HR Assistant

20 Jan 2022 - Online webinar

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Presented by Jocelyn Hughes (bio)

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Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

27-28 Jan 2022 - Online webinar

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Presented by Laura Brown (bio)

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Negotiating and Drafting IT (Information Technology) Contracts Training Course

Negotiating and Drafting IT Contracts

31 Jan-1 Feb 2022 - London

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Presented by Mark Weston (bio)

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February 2022 training courses

Drafting International Intellectual Property Agreements Training Course

Drafting International Intellectual Property Agreements

1 Feb 2022 - London

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

Common Technical Document Training Course

Common Technical Document

1-2 Feb 2022 - London

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

1-2 Feb 2022 - London

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

View details

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

1-2 Feb 2022 - London

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

View details

Litigation-Proofing and Proving your Patent Claims Training Course

Litigation-Proofing and Proving your Patent Claims

1 Feb 2022 - London

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

Presented by Ulrich Blumenroeder (bio)
Bradley Hulbert (bio)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

3-4 Feb 2022 - Online webinar

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Presented by Anna Harrington-Morozova (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

8-10 Feb 2022 - London

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

View details

The Art of European Claim Drafting Training Course

The Art of European Claim Drafting

8-9 Feb 2022 - London

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Presented by Joeri Beetz (bio)
Leythem Wall (bio)

View details

Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

8-9 Feb 2022 - London

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Presented by Philip Clay (bio)
Janine Ingleby (bio)

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Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

Drafting Commercial Contracts for the Pharmaceutical Industry

8-10 Feb 2022 - London

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Presented by James Agnew (bio)
and 15 more leading experts

View details

Drafting International Commercial Agreements in English Training Course

Drafting International Commercial Agreements in English

8-10 Feb 2022 - London

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Presented by Alan Simmons (bio)

View details

Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

9 Feb 2022 - Online webinar

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

View details

Presenting Virtually Training Course

Presenting Virtually

10 Feb 2022 - Online webinar

During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

22-23 Feb 2022 - London

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

22-23 Feb 2022 - London

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Formal Requirements of the European Patent System Training Course

Formal Requirements of the European Patent System

22-23 Feb 2022 - London

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Presented by Petra Schmitz (bio)

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The Role and Responsibilities of the Contracts Manager Training Course

The Role and Responsibilities of the Contracts Manager

22-23 Feb 2022 - London

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

Presented by Catherine Hurst (bio)

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The Pharma Mini MBA Training Course

The Pharma Mini MBA

23-25 Feb 2022 - London

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

Presented by Laura Brown (bio)

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Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

24 Feb 2022 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)

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The Patent Administrator Training Course

The Patent Administrator

25 Feb 2022 - London

This course will give you a comprehensive introduction to the role of the patent administrator

Presented by JoAnna Emery (bio)

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March 2022 training courses

US Patent Practice Training Course

US Patent Practice

1-2 Mar 2022 - London

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Presented by Nicole Reifman (bio)
James Suggs (bio)

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Business and Contract Law Training Course

Business and Contract Law

1-2 Mar 2022 - London

A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Presented by Arun Singh OBE (bio)

View details

Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

1-3 Mar 2022 - Online webinar

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

1-2 Mar 2022 - Online webinar

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

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An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

1 Mar 2022 - Online webinar

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Presented by Laura Brown (bio)

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3-day Drafting Commercial Contracts Training Course

3-day Drafting Commercial Contracts

1-3 Mar 2022 - London

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Presented by Mark Weston (bio)

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Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations Training Course

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations

2 Mar 2022 - Online webinar

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

Presented by Simon Portman (bio)

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Drafting International R&D Collaboration and Joint Venture Agreements Training Course

Drafting International R&D Collaboration and Joint Venture Agreements

3 Mar 2022 - Online webinar

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Presented by Rebecca Attree (bio)

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Agile Leadership for Pharma and Biopharma Professionals in a virtual world Training Course

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

3-4 Mar 2022 - Online webinar

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

Presented by Laura Brown (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

7-9 Mar 2022 - Online webinar

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Adrian Haines (bio)
and 6 more leading experts

View details

Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

8-9 Mar 2022 - Online webinar

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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EPO (European Patent Office) Oppositions and Appeals - the Case Law and Workshop Training Course

EPO Oppositions and Appeals - the Case Law and Workshop

8-9 Mar 2022 - Online webinar

Updated for 2021! Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

Presented by Graham Ashley (bio)
Leythem Wall (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

9-10 Mar 2022 - Online webinar

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Ownership and Control of Intellectual Property Rights Training Course

Ownership and Control of Intellectual Property Rights

9 Mar 2022 - Online webinar

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

Presented by Mark Weston (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

10 Mar 2022 - Online webinar

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

Presented by Laura Brown (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

10-11 Mar 2022 - Online webinar

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
Elizabeth Baker (bio)
David Jefferys (bio)

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Process Validation with Qualification Training Course

Process Validation with Qualification

14-15 Mar 2022 - Online webinar

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Managing Remote Teams Training Course

Managing Remote Teams

14 Mar 2022 - Online webinar

During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Running Virtual Meetings Training Course

Running Virtual Meetings

15 Mar 2022 - Online webinar

This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

16 Mar 2022 - Online webinar

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Marloes van der Geer (bio)

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The Role of the Senior HR Manager Training Course

The Role of the Senior HR Manager

16-17 Mar 2022 - Online webinar

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

Presented by Jocelyn Hughes (bio)

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A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

17-18 Mar 2022 - Online webinar

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Presented by Tamsin Dawson (bio)
Mel Munro (bio)

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Liabilities, Damages and other Contentious Issues in International Commercial Agreements Training Course

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

21-22 Mar 2022 - Online webinar

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Presented by Arun Singh OBE (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

21-22 Mar 2022 - Online webinar

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Strategic IP (Intellectual Property) Planning Training Course

Strategic IP Planning

21-25 Mar 2022 - Online webinar

A step-by-step practical guide to strategic IP planning

Presented by Arnaud Gasnier (bio)

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4-day International Commercial Contracts School Training Course

4-day International Commercial Contracts School

21-24 Mar 2022 - Online webinar

This specially designed four-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Presented by Mark Weston (bio)

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Understanding and Managing Competition Law Compliance Training Course

Understanding and Managing Competition Law Compliance

23 Mar 2022 - Online webinar

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

Presented by Rebecca Attree (bio)

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Project Management for Pharma Professionals Training Course

Project Management for Pharma Professionals

24-25 Mar 2022 - Online webinar

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

Presented by Laura Brown (bio)

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Patent Protection for Software-Related Inventions in Europe and the USA Training Course

Patent Protection for Software-Related Inventions in Europe and the USA

25 Mar 2022 - Online webinar

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Presented by Alan Boyd (bio)
Tim May (bio)
Andy Spurr (bio)

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

28-29 Mar 2022 - Online webinar

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

28-29 Mar 2022 - Online webinar

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Presented by Norah Lightowler (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

29-30 Mar 2022 - Online webinar

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

30-31 Mar 2022 - Online webinar

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Presented by Dale Charlton (bio)
Andreas Rothmund (bio)
Patrik Thoma (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2022 - Online webinar

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

Presented by John Price (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

31 Mar-1 Apr 2022 - Online webinar

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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MBA Strategic Thinking for Pharma and Biopharma Professionals Training Course

MBA Strategic Thinking for Pharma and Biopharma Professionals

31 Mar-1 Apr 2022 - Online webinar

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.

Presented by Laura Brown (bio)

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April 2022 training courses

Drafting Commercial Contracts Training Course

Drafting Commercial Contracts

4-5 Apr 2022 - Online webinar

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Presented by Mark Weston (bio)

View details

Biosimilars Training Course

Biosimilars

4-5 Apr 2022 - Online webinar

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Marloes van der Geer (bio)

View details

A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

4 Apr 2022 - London

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

View details

Data Integrity and Document Management Training Course

Data Integrity and Document Management

5 Apr 2022 - Online webinar

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Presented by Laura Brown (bio)

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

5-6 Apr 2022 - Online webinar

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

5 Apr 2022 - London

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

6-7 Apr 2022 - Online webinar

How to produce quality regulatory documents including the clinical evaluation report (CER)

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

View details

Dealing With Difficult People Training Course

Dealing With Difficult People

6 Apr 2022 - Online webinar

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is an interactive online course consisting of 2 x 90 minute modules.

Presented by Geoff Marsh (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

6-7 Apr 2022 - Online webinar

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

7-8 Apr 2022 - Online webinar

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Presented by Laura Brown (bio)

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Employment Law in Practice from Recruitment to Termination Training Course

Employment Law in Practice from Recruitment to Termination

7-8 Apr 2022 - Online webinar

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Presented by Toni Trevett (bio)

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An Essential Overview of Pharmacovigilance Training Course

An Essential Overview of Pharmacovigilance

8 Apr 2022 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Presented by Graeme Ladds (bio)

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Freedom-to-Operate Searching Training Course

Freedom-to-Operate Searching

11 Apr 2022 - Online webinar

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

Presented by Stephen Adams (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

11-12 Apr 2022 - Online webinar

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.

The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

Presented by Norah Lightowler (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

11-12 Apr 2022 - Online webinar

Optimising oversight for inspection compliance

Presented by Laura Brown (bio)

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How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace Training Course

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

11 Apr 2022 - Online webinar

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

Presented by Toni Trevett (bio)

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New Medical Device Regulation Training Course

New Medical Device Regulation

12-13 Apr 2022 - Online webinar

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

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Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course

Medical Device Regulation in the Eurasian Union, Russia and the CIS

12-13 Apr 2022 - Online webinar

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Presented by Anna Harrington-Morozova (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

20-22 Apr 2022 - Online webinar

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

25-26 Apr 2022 - Online webinar

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Filing eCTD Submissions Training Course

Filing eCTD Submissions

25 Apr 2022 - Online webinar

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

25 Apr 2022 - Online webinar

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Presented by Joanne Flitcroft (bio)
Graeme Ladds (bio)

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Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

25-28 Apr 2022 - Online webinar

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

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Introduction to Veterinary Pharmacovigilance Training Course

Introduction to Veterinary Pharmacovigilance

26-27 Apr 2022 - Online webinar

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Presented by Declan O'Rourke (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

26-27 Apr 2022 - Online webinar

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Presented by Marloes van der Geer (bio)

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Nasal Drug Delivery Training Course

Nasal Drug Delivery

26-27 Apr 2022 - Online webinar

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Presented by Michael Benninger (bio)
and 12 more leading experts

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Negotiating and Drafting IT (Information Technology) Contracts Training Course

Negotiating and Drafting IT Contracts

27-28 Apr 2022 - Online webinar

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Presented by Mark Weston (bio)

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Successful Medical Writing Training Course

Successful Medical Writing

27-29 Apr 2022 - Online webinar

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Presented by Barry Drees (bio)
Barbara Grossman (bio)
James Visanji (bio)

View details

Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

28-29 Apr 2022 - Online webinar

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Presented by Julian Braidwood (bio)
Marie-Pascale Tiberghien (bio)

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Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

29 Apr 2022 - Online webinar

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

Presented by Laura Brown (bio)

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May 2022 training courses

Advanced Drafting Techniques for Successful EPO (European Patent Office) Patent Applications Training Course

Advanced Drafting Techniques for Successful EPO Patent Applications

4 May 2022 - Online webinar

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

4-5 May 2022 - Online webinar

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

4-5 May 2022 - Online webinar

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

View details

Developing High Performance HR Business Partner and Consulting Skills Training Course

Developing High Performance HR Business Partner and Consulting Skills

4-5 May 2022 - London

Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.

Presented by Katie Botten (bio)

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Effectively Managing Legal Risk and Preserving Reputation Training Course

Effectively Managing Legal Risk and Preserving Reputation

4-5 May 2022 - London

This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

Presented by Justin Weare (bio)
Ian White (bio)

View details

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

5-6 May 2022 - Online webinar

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Common Technical Document Training Course

Common Technical Document

5-6 May 2022 - Online webinar

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Root Cause Analysis and Critical Thinking Training Course

Root Cause Analysis and Critical Thinking

6 May 2022 - Online webinar

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

Presented by Laura Brown (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

9-10 May 2022 - Online webinar

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)

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Drafting and Negotiating International Agency and Distribution Agreements Training Course

Drafting and Negotiating International Agency and Distribution Agreements

9-10 May 2022 - Online webinar

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*

Presented by Michala Meiselles (bio)

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Formal Requirements of the European Patent System Training Course

Formal Requirements of the European Patent System

9-10 May 2022 - Online webinar

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Presented by Petra Schmitz (bio)

View details

Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

Drafting Commercial Contracts for the Pharmaceutical Industry

9-11 May 2022 - Online webinar

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Presented by James Agnew (bio)
and 15 more leading experts

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Drafting International Commercial Agreements in English Training Course

Drafting International Commercial Agreements in English

10-12 May 2022 - Online webinar

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Presented by Alan Simmons (bio)

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How to Avoid Common Pitfalls in Combined EU (European Union)/US Patent Applications Training Course

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

11-12 May 2022 - Online webinar

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Presented by Bradley Hulbert (bio)
David Meldrum (bio)

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Effective Defence of EPO (European Patent Office) Patent Applications Training Course

Effective Defence of EPO Patent Applications

11 May 2022 - Online webinar

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

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Influencing, Persuading and Negotiating Skills for International Lawyers Training Course

Influencing, Persuading and Negotiating Skills for International Lawyers

12-13 May 2022 - Online webinar

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Presented by Arun Singh OBE (bio)

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IP (Intellectual Property) Due Diligence & Freedom to Operate in Practice Training Course

IP Due Diligence & Freedom to Operate in Practice

12 May 2022 - Online webinar

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Presented by Tim May (bio)
and 3 more leading experts

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How to Improve Accuracy and Attention to Detail Training Course

How to Improve Accuracy and Attention to Detail

13 May 2022 - Online webinar

Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working

Presented by Laura Brown (bio)

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Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

13 May 2022 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)

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The Patent Administrator Training Course

The Patent Administrator

13 May 2022 - Online webinar

This course will give you a comprehensive introduction to the role of the patent administrator

Presented by JoAnna Emery (bio)

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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

16-17 May 2022 - Online webinar

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

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The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The New EU Animal Health Legislation for Veterinary Medicinal Products

16-17 May 2022 - Online webinar

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

Presented by Julian Braidwood (bio)

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Recruiting a High Performance Global Workforce Within the Law Training Course

Recruiting a High Performance Global Workforce Within the Law

16-17 May 2022 - Online webinar

An intensive and practical two-day programme for HR professionals and line managers.

Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.

Presented by Jocelyn Hughes (bio)

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Drafting Effective Pharmaceutical Patents Training Course

Drafting Effective Pharmaceutical Patents

17-18 May 2022 - Online webinar

*New for 2020!*
Drafting successful pharmaceutical patents is complex and there are many pitfalls and risks to be aware of. You need to ensure you’re maximising the protection for your, and your client’s, pharmaceutical inventions thorough both primary and secondary pharmaceutical patents.

Presented by Anthony Tridico (bio)

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Positive Persuading and Influencing Skills for Pharma Professionals Training Course

Positive Persuading and Influencing Skills for Pharma Professionals

17-18 May 2022 - Online webinar

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

Presented by Robert Hersowitz (bio)

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The Mini MBA for In-house Lawyers Training Course

The Mini MBA for In-house Lawyers

17-20 May 2022 - London

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

Presented by Graham Boyd (bio)
Robert Mowbray (bio)

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The Pharma Mini MBA Training Course

The Pharma Mini MBA

18-20 May 2022 - Online webinar

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

Presented by Laura Brown (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

18-20 May 2022 - Online webinar

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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The Role and Responsibilities of the Contracts Manager Training Course

The Role and Responsibilities of the Contracts Manager

18-19 May 2022 - Online webinar

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

Presented by Catherine Hurst (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

19-20 May 2022 - Online webinar

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)
Nancy Consterdine (bio)

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Litigation-Proofing and Proving your Patent Claims Training Course

Litigation-Proofing and Proving your Patent Claims

20 May 2022 - Online webinar

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

Presented by Ulrich Blumenroeder (bio)
Bradley Hulbert (bio)

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Clean Communication Training Course

Clean Communication

20 May 2022 - Online webinar

Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

23 May 2022 - Online webinar

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

23-24 May 2022 - Online webinar

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Presented by Graeme Ladds (bio)

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Mental Resilience in a Home-working Environment Training Course

Mental Resilience in a Home-working Environment

23 May 2022 - Online webinar

This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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IP (Intellectual Property) Department Roadmap Training Course

IP Department Roadmap

23-24 May 2022 - Online webinar

This course provides a step-by-step, matrix-based methodology with a top-down and cross-functional approach to design an IP department roadmap

Presented by Arnaud Gasnier (bio)

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The Art of European Claim Drafting Training Course

The Art of European Claim Drafting

24-25 May 2022 - Online webinar

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Presented by Joeri Beetz (bio)
Leythem Wall (bio)

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Drafting International Intellectual Property Agreements Training Course

Drafting International Intellectual Property Agreements

24 May 2022 - Online webinar

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

Technical Documentation to Comply with the MDR and IVDR

25-26 May 2022 - Online webinar

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Presented by Will Burton (bio)
Paul Sim (bio)

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

25-26 May 2022 - Online webinar

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Presented by Salma Ismail (bio)
Makram Nehme (bio)

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Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

25-26 May 2022 - Online webinar

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

26-27 May 2022 - Online webinar

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Reviewing and Negotiating Technology Transfer and Licensing Agreements Training Course

Reviewing and Negotiating Technology Transfer and Licensing Agreements

26-27 May 2022 - Online webinar

Providing key legal and commercial skills essential to secure a successful agreement.

Presented by Michala Meiselles (bio)

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June 2022 training courses

Drafting International R&D Collaboration and Joint Venture Agreements Training Course

Drafting International R&D Collaboration and Joint Venture Agreements

7 Jun 2022 - London

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Presented by Rebecca Attree (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

7-8 Jun 2022 - London

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

7-8 Jun 2022 - London

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
Elizabeth Baker (bio)
David Jefferys (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

7-9 Jun 2022 - London

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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US Patent Practice Training Course

US Patent Practice

8-9 Jun 2022 - Online webinar

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Presented by Nicole Reifman (bio)
James Suggs (bio)

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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

9-10 Jun 2022 - Online webinar

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Presented by Julian Braidwood (bio)

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5-day International Commercial Contracts School Training Course

5-day International Commercial Contracts School

12-16 Jun 2022 - London

This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Presented by Arun Singh OBE (bio)

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Business and Contract Law Training Course

Business and Contract Law

13-14 Jun 2022 - Online webinar

A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Presented by Arun Singh OBE (bio)

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

13-14 Jun 2022 - Online webinar

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

13-17 Jun 2022 - Online webinar

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Janette Benaddi (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

15-16 Jun 2022 - London

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

15-16 Jun 2022 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

15 Jun 2022 - London

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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Liabilities, Damages and other Contentious Issues in International Commercial Agreements Training Course

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

15-16 Jun 2022 - London

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Presented by Arun Singh OBE (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

16 Jun 2022 - London

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

Presented by Laura Brown (bio)

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

16 Jun 2022 - Online webinar

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

Presented by Brian Kelly (bio)
David Richardson (bio)
Penny Viner (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

20-21 Jun 2022 - London

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Process Validation with Qualification Training Course

Process Validation with Qualification

20-21 Jun 2022 - London

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Registration of Animal Feed Additives in the EU (European Union) Training Course

Registration of Animal Feed Additives in the EU

20-21 Jun 2022 - Online webinar

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Presented by Elinor McCartney (bio)

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Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

Working Through Veterinary Drug Development in the EU and USA

20-24 Jun 2022 - Online webinar

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

Presented by Julian Braidwood (bio)
David Petrick (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

20-21 Jun 2022 - London

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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Project Management for Pharma Professionals Training Course

Project Management for Pharma Professionals

20-21 Jun 2022 - London

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

Presented by Laura Brown (bio)

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Ownership and Control of Intellectual Property Rights Training Course

Ownership and Control of Intellectual Property Rights

20 Jun 2022 - London

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

Presented by Mark Weston (bio)

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Pharmacovigilance Training Course

Pharmacovigilance

21-23 Jun 2022 - Online webinar

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Presented by Glyn Belcher (bio)
and 6 more leading experts

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

27 Jun 2022 - London

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Marloes van der Geer (bio)

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3-day Drafting Commercial Contracts Training Course

3-day Drafting Commercial Contracts

27-29 Jun 2022 - Online webinar

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Presented by Mark Weston (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

27 Jun 2022 - Online webinar

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

27-29 Jun 2022 - London

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Adrian Haines (bio)
and 6 more leading experts

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

27-28 Jun 2022 - London

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 6 more leading experts

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Jun 2022 - London

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Presented by Norah Lightowler (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

28 Jun 2022 - Online webinar

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Presented by Laura Brown (bio)

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

28-29 Jun 2022 - Online webinar

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

29-30 Jun 2022 - Online webinar

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

30 Jun-1 Jul 2022 - London

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Presented by Julian Braidwood (bio)
Marie-Pascale Tiberghien (bio)

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July 2022 training courses

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

4-7 Jul 2022 - London

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

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Biosimilars Training Course

Biosimilars

4-5 Jul 2022 - London

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Marloes van der Geer (bio)

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

4-5 Jul 2022 - London

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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Drafting Commercial Contracts Training Course

Drafting Commercial Contracts

4-5 Jul 2022 - London

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Presented by Mark Weston (bio)

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Dealing With Difficult People Training Course

Dealing With Difficult People

4 Jul 2022 - London

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is an interactive online course consisting of 2 x 90 minute modules.

Presented by Geoff Marsh (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

4-5 Jul 2022 - London

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

4-5 Jul 2022 - London

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Presented by Laura Brown (bio)

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How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace Training Course

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

4 Jul 2022 - London

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

Presented by Toni Trevett (bio)

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Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course

Medical Device Regulation in the Eurasian Union, Russia and the CIS

5-6 Jul 2022 - London

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Presented by Anna Harrington-Morozova (bio)

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Introduction to Veterinary Pharmacovigilance Training Course

Introduction to Veterinary Pharmacovigilance

5-6 Jul 2022 - London

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Presented by Declan O'Rourke (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

5-6 Jul 2022 - London

How to produce quality regulatory documents including the clinical evaluation report (CER)

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

5-6 Jul 2022 - London

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.

The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

Presented by Norah Lightowler (bio)

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The Role of an Effective HR Advisor Training Course

The Role of an Effective HR Advisor

5-6 Jul 2022 - Online webinar

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Presented by Jocelyn Hughes (bio)

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Employment Law in Practice from Recruitment to Termination Training Course

Employment Law in Practice from Recruitment to Termination

5-6 Jul 2022 - London

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Presented by Toni Trevett (bio)

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Data Integrity and Document Management Training Course

Data Integrity and Document Management

7 Jul 2022 - London

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Presented by Laura Brown (bio)

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The Role and Skills of a Valuable HR Assistant Training Course

The Role and Skills of a Valuable HR Assistant

7 Jul 2022 - Online webinar

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Presented by Jocelyn Hughes (bio)

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New Medical Device Regulation Training Course

New Medical Device Regulation

11-12 Jul 2022 - London

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

11 Jul 2022 - Online webinar

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

11 Jul 2022 - London

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

11-12 Jul 2022 - London

Optimising oversight for inspection compliance

Presented by Laura Brown (bio)

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Negotiating and Drafting IT (Information Technology) Contracts Training Course

Negotiating and Drafting IT Contracts

11-12 Jul 2022 - London

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Presented by Mark Weston (bio)

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Successful Medical Writing Training Course

Successful Medical Writing

11-13 Jul 2022 - London

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Presented by Barry Drees (bio)
Barbara Grossman (bio)
James Visanji (bio)

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A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

12 Jul 2022 - Online webinar

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

13 Jul 2022 - London

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Presented by Joanne Flitcroft (bio)
Graeme Ladds (bio)

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The Role of the Senior HR Manager Training Course

The Role of the Senior HR Manager

13-14 Jul 2022 - Online webinar

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

Presented by Jocelyn Hughes (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

13-14 Jul 2022 - London

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

14-15 Jul 2022 - Online webinar

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Presented by Laura Brown (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

14-15 Jul 2022 - Online webinar

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Ray Munden (bio)
Allan Watkinson (bio)

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August 2022 training courses

Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

1 Aug 2022 - London

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

1-2 Aug 2022 - London

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

1-3 Aug 2022 - London

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

1-2 Aug 2022 - London

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Presented by Philip Clay (bio)
Janine Ingleby (bio)

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Drafting International Intellectual Property Agreements Training Course

Drafting International Intellectual Property Agreements

8 Aug 2022 - London

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Aug 2022 - London

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

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Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

Drafting Commercial Contracts for the Pharmaceutical Industry

8-10 Aug 2022 - London

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Presented by James Agnew (bio)
and 15 more leading experts

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Drafting International Commercial Agreements in English Training Course

Drafting International Commercial Agreements in English

8-10 Aug 2022 - London

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Presented by Alan Simmons (bio)

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Formal Requirements of the European Patent System Training Course

Formal Requirements of the European Patent System

8-9 Aug 2022 - London

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Presented by Petra Schmitz (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

15-16 Aug 2022 - London

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)

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How to Avoid Common Pitfalls in Combined EU (European Union)/US Patent Applications Training Course

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

15-16 Aug 2022 - London

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Presented by Bradley Hulbert (bio)
David Meldrum (bio)

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Influencing, Persuading and Negotiating Skills for International Lawyers Training Course

Influencing, Persuading and Negotiating Skills for International Lawyers

15-16 Aug 2022 - London

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Presented by Arun Singh OBE (bio)

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IP (Intellectual Property) Due Diligence & Freedom to Operate in Practice Training Course

IP Due Diligence & Freedom to Operate in Practice

15 Aug 2022 - London

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Presented by Tim May (bio)
and 3 more leading experts

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

15-16 Aug 2022 - Online webinar

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Presented by Anna Harrington-Morozova (bio)

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September 2022 training courses

5-day International Commercial Contracts School Training Course

5-day International Commercial Contracts School

5-9 Sep 2022 - Online webinar

This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Presented by Arun Singh OBE (bio)

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A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

6-7 Sep 2022 - Online webinar

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Presented by Tamsin Dawson (bio)
Mel Munro (bio)

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Managing Remote Teams Training Course

Managing Remote Teams

7 Sep 2022 - Online webinar

During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Ownership and Control of Intellectual Property Rights Training Course

Ownership and Control of Intellectual Property Rights

7 Sep 2022 - Online webinar

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

Presented by Mark Weston (bio)

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Project Management for Pharma Professionals Training Course

Project Management for Pharma Professionals

8-9 Sep 2022 - Online webinar

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

Presented by Laura Brown (bio)

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EPO (European Patent Office) Oppositions and Appeals - the Case Law and Workshop Training Course

EPO Oppositions and Appeals - the Case Law and Workshop

8-9 Sep 2022 - Online webinar

Updated for 2021! Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

Presented by Graham Ashley (bio)
Leythem Wall (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

8 Sep 2022 - Online webinar

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

Presented by John Price (bio)

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Strategic IP (Intellectual Property) Planning Training Course

Strategic IP Planning

12-14 Sep 2022 - Online webinar

A step-by-step practical guide to strategic IP planning

Presented by Arnaud Gasnier (bio)

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Liabilities, Damages and other Contentious Issues in International Commercial Agreements Training Course

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

12-13 Sep 2022 - Online webinar

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Presented by Arun Singh OBE (bio)

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Running Virtual Meetings Training Course

Running Virtual Meetings

12 Sep 2022 - Online webinar

This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

12-13 Sep 2022 - Online webinar

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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MBA Strategic Thinking for Pharma and Biopharma Professionals Training Course

MBA Strategic Thinking for Pharma and Biopharma Professionals

12-13 Sep 2022 - Online webinar

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.

Presented by Laura Brown (bio)

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Presenting Virtually Training Course

Presenting Virtually

13 Sep 2022 - Online webinar

During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

13-14 Sep 2022 - Online webinar

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

14-15 Sep 2022 - Online webinar

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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Drafting International R&D Collaboration and Joint Venture Agreements Training Course

Drafting International R&D Collaboration and Joint Venture Agreements

15 Sep 2022 - Online webinar

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Presented by Rebecca Attree (bio)

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An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

16 Sep 2022 - Online webinar

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Presented by Laura Brown (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

19-20 Sep 2022 - Online webinar

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

19-20 Sep 2022 - Online webinar

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations Training Course

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations

19 Sep 2022 - Online webinar

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

Presented by Simon Portman (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

19 Sep 2022 - London

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

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Pharmacovigilance Training Course

Pharmacovigilance

20-22 Sep 2022 - London

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Presented by Glyn Belcher (bio)
and 6 more leading experts

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3-day Drafting Commercial Contracts Training Course

3-day Drafting Commercial Contracts

20-22 Sep 2022 - London

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Presented by Mark Weston (bio)

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Business and Contract Law Training Course

Business and Contract Law

20-21 Sep 2022 - London

A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Presented by Arun Singh OBE (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

20 Sep 2022 - London

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Presented by Laura Brown (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

20-21 Sep 2022 - London

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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The Role of an Effective HR Advisor Training Course

The Role of an Effective HR Advisor

20-21 Sep 2022 - London

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Presented by Jocelyn Hughes (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

21-23 Sep 2022 - Online webinar

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

21-22 Sep 2022 - Online webinar

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Presented by Dale Charlton (bio)
Andreas Rothmund (bio)
Patrik Thoma (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

22 Sep 2022 - Online webinar

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

Presented by Laura Brown (bio)

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Process Validation with Qualification Training Course

Process Validation with Qualification

26-27 Sep 2022 - Online webinar

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

26 Sep 2022 - Online webinar

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Marloes van der Geer (bio)

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Patent Protection for Software-Related Inventions in Europe and the USA Training Course

Patent Protection for Software-Related Inventions in Europe and the USA

27 Sep 2022 - Online webinar

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Presented by Alan Boyd (bio)
Tim May (bio)
Andy Spurr (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Sep 2022 - Online webinar

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Presented by Norah Lightowler (bio)

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

27-28 Sep 2022 - Online webinar

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

28-30 Sep 2022 - Online webinar

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Adrian Haines (bio)
and 6 more leading experts

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

28-29 Sep 2022 - Online webinar

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

29-30 Sep 2022 - Online webinar

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
Elizabeth Baker (bio)
David Jefferys (bio)

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Agile Leadership for Pharma and Biopharma Professionals in a virtual world Training Course

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

29-30 Sep 2022 - Online webinar

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

Presented by Laura Brown (bio)

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Understanding and Managing Competition Law Compliance Training Course

Understanding and Managing Competition Law Compliance

29 Sep 2022 - Online webinar

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

Presented by Rebecca Attree (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

30 Sep 2022 - Online webinar

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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October 2022 training courses

The Role and Skills of a Valuable HR Assistant Training Course

The Role and Skills of a Valuable HR Assistant

3 Oct 2022 - London

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Presented by Jocelyn Hughes (bio)

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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

3 Oct 2022 - London

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

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Nasal Drug Delivery Training Course

Nasal Drug Delivery

4-5 Oct 2022 - London

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Presented by Michael Benninger (bio)
and 12 more leading experts

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

4-5 Oct 2022 - Online webinar

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

4-7 Oct 2022 - Online webinar

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

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A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

4 Oct 2022 - London

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

6-7 Oct 2022 - Online webinar

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Data Integrity and Document Management Training Course

Data Integrity and Document Management

10 Oct 2022 - Online webinar

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Presented by Laura Brown (bio)

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An Essential Overview of Pharmacovigilance Training Course

An Essential Overview of Pharmacovigilance

10 Oct 2022 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Presented by Graeme Ladds (bio)

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Successful Medical Writing Training Course

Successful Medical Writing

11-13 Oct 2022 - Online webinar

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Presented by Barry Drees (bio)
Barbara Grossman (bio)
James Visanji (bio)

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Biosimilars Training Course

Biosimilars

11-12 Oct 2022 - Online webinar

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Marloes van der Geer (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

11-12 Oct 2022 - Online webinar

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course

Medical Device Regulation in the Eurasian Union, Russia and the CIS

12-13 Oct 2022 - Online webinar

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Presented by Anna Harrington-Morozova (bio)

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Employment Law in Practice from Recruitment to Termination Training Course

Employment Law in Practice from Recruitment to Termination

12-13 Oct 2022 - Online webinar

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Presented by Toni Trevett (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

12-14 Oct 2022 - Online webinar

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

13-14 Oct 2022 - Online webinar

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Presented by Marloes van der Geer (bio)

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Freedom-to-Operate Searching Training Course

Freedom-to-Operate Searching

13 Oct 2022 - Online webinar

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

Presented by Stephen Adams (bio)

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New Medical Device Regulation Training Course

New Medical Device Regulation

13-14 Oct 2022 - Online webinar

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

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Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

14 Oct 2022 - Online webinar

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

Presented by Laura Brown (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

17-18 Oct 2022 - Online webinar

Optimising oversight for inspection compliance

Presented by Laura Brown (bio)

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

17 Oct 2022 - Online webinar

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Presented by Joanne Flitcroft (bio)
Graeme Ladds (bio)

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How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace Training Course

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

17 Oct 2022 - Online webinar

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

Presented by Toni Trevett (bio)

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Introduction to Veterinary Pharmacovigilance Training Course

Introduction to Veterinary Pharmacovigilance

18-19 Oct 2022 - Online webinar

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Presented by Declan O'Rourke (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

18-19 Oct 2022 - Online webinar

The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.

The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.

Presented by Norah Lightowler (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

19 Oct 2022 - Online webinar

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

19-20 Oct 2022 - Online webinar

How to produce quality regulatory documents including the clinical evaluation report (CER)

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

20-21 Oct 2022 - Online webinar

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Presented by Laura Brown (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

20-21 Oct 2022 - Online webinar

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Presented by Julian Braidwood (bio)
Marie-Pascale Tiberghien (bio)

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Dealing With Difficult People Training Course

Dealing With Difficult People

20 Oct 2022 - Online webinar

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is an interactive online course consisting of 2 x 90 minute modules.

Presented by Geoff Marsh (bio)

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November 2022 training courses

Drafting Commercial Contracts Training Course

Drafting Commercial Contracts

1-2 Nov 2022 - Online webinar

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Presented by Mark Weston (bio)

View details

How to Improve Accuracy and Attention to Detail Training Course

How to Improve Accuracy and Attention to Detail

1 Nov 2022 - Online webinar

Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working

Presented by Laura Brown (bio)

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The Mini MBA for In-house Lawyers Training Course

The Mini MBA for In-house Lawyers

1-4 Nov 2022 - London

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

Presented by Graham Boyd (bio)
Robert Mowbray (bio)

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The Role of the Senior HR Manager Training Course

The Role of the Senior HR Manager

1-2 Nov 2022 - London

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

Presented by Jocelyn Hughes (bio)

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Effectively Managing Legal Risk and Preserving Reputation Training Course

Effectively Managing Legal Risk and Preserving Reputation

1-2 Nov 2022 - London

This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

Presented by Justin Weare (bio)
Ian White (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

2 Nov 2022 - Online webinar

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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How to Avoid Common Pitfalls in Combined EU (European Union)/US Patent Applications Training Course

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

2-3 Nov 2022 - Online webinar

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Presented by Bradley Hulbert (bio)
David Meldrum (bio)

View details

The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The New EU Animal Health Legislation for Veterinary Medicinal Products

3-4 Nov 2022 - Online webinar

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

Presented by Julian Braidwood (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

3-4 Nov 2022 - Online webinar

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)
Nancy Consterdine (bio)

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Recruiting a High Performance Global Workforce Within the Law Training Course

Recruiting a High Performance Global Workforce Within the Law

3-4 Nov 2022 - Online webinar

An intensive and practical two-day programme for HR professionals and line managers.

Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.

Presented by Jocelyn Hughes (bio)

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Drafting Effective Pharmaceutical Patents Training Course

Drafting Effective Pharmaceutical Patents

3-4 Nov 2022 - Online webinar

*New for 2020!*
Drafting successful pharmaceutical patents is complex and there are many pitfalls and risks to be aware of. You need to ensure you’re maximising the protection for your, and your client’s, pharmaceutical inventions thorough both primary and secondary pharmaceutical patents.

Presented by Anthony Tridico (bio)

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Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

4 Nov 2022 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)

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Negotiating and Drafting IT (Information Technology) Contracts Training Course

Negotiating and Drafting IT Contracts

7-8 Nov 2022 - Online webinar

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Presented by Mark Weston (bio)

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Reviewing and Negotiating Technology Transfer and Licensing Agreements Training Course

Reviewing and Negotiating Technology Transfer and Licensing Agreements

7-8 Nov 2022 - Online webinar

Providing key legal and commercial skills essential to secure a successful agreement.

Presented by Michala Meiselles (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

7-8 Nov 2022 - Online webinar

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Influencing, Persuading and Negotiating Skills for International Lawyers Training Course

Influencing, Persuading and Negotiating Skills for International Lawyers

7-8 Nov 2022 - Online webinar

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Presented by Arun Singh OBE (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

8-10 Nov 2022 - Online webinar

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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Clean Communication Training Course

Clean Communication

9 Nov 2022 - Online webinar

Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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The Pharma Mini MBA Training Course

The Pharma Mini MBA

9-11 Nov 2022 - Online webinar

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

Presented by Laura Brown (bio)

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The Art of European Claim Drafting Training Course

The Art of European Claim Drafting

10-11 Nov 2022 - Online webinar

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Presented by Joeri Beetz (bio)
Leythem Wall (bio)

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Advanced Drafting Techniques for Successful EPO (European Patent Office) Patent Applications Training Course

Advanced Drafting Techniques for Successful EPO Patent Applications

10 Nov 2022 - Online webinar

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

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Effective Defence of EPO (European Patent Office) Patent Applications Training Course

Effective Defence of EPO Patent Applications

11 Nov 2022 - Online webinar

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Presented by Daniel X Thomas (bio)

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Mental Resilience in a Home-working Environment Training Course

Mental Resilience in a Home-working Environment

11 Nov 2022 - Online webinar

This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presented by Geoff Marsh (bio)

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Drafting and Negotiating International Agency and Distribution Agreements Training Course

Drafting and Negotiating International Agency and Distribution Agreements

14-15 Nov 2022 - Online webinar

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*

Presented by Michala Meiselles (bio)

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Positive Persuading and Influencing Skills for Pharma Professionals Training Course

Positive Persuading and Influencing Skills for Pharma Professionals

14-15 Nov 2022 - Online webinar

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

Presented by Robert Hersowitz (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

14-15 Nov 2022 - Online webinar

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)

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Developing High Performance HR Business Partner and Consulting Skills Training Course

Developing High Performance HR Business Partner and Consulting Skills

15-16 Nov 2022 - Online webinar

Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.

Presented by Katie Botten (bio)

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Drafting International Commercial Agreements in English Training Course

Drafting International Commercial Agreements in English

15-17 Nov 2022 - Online webinar

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

Presented by Alan Simmons (bio)

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Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

16-17 Nov 2022 - Online webinar

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Presented by Graeme Ladds (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

17-18 Nov 2022 - Online webinar

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Formal Requirements of the European Patent System Training Course

Formal Requirements of the European Patent System

17-18 Nov 2022 - Online webinar

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Presented by Petra Schmitz (bio)

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Drafting International Intellectual Property Agreements Training Course

Drafting International Intellectual Property Agreements

18 Nov 2022 - Online webinar

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

Root Cause Analysis and Critical Thinking Training Course

Root Cause Analysis and Critical Thinking

21 Nov 2022 - Online webinar

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

Presented by Laura Brown (bio)

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

21-22 Nov 2022 - Online webinar

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

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Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

Technical Documentation to Comply with the MDR and IVDR

22-23 Nov 2022 - Online webinar

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Presented by Will Burton (bio)
Paul Sim (bio)

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Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

22-23 Nov 2022 - Online webinar

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Litigation-Proofing and Proving your Patent Claims Training Course

Litigation-Proofing and Proving your Patent Claims

22 Nov 2022 - Online webinar

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

Presented by Ulrich Blumenroeder (bio)
Bradley Hulbert (bio)

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The Role and Responsibilities of the Contracts Manager Training Course

The Role and Responsibilities of the Contracts Manager

23-24 Nov 2022 - Online webinar

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

Presented by Catherine Hurst (bio)

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Drafting Commercial Contracts for the Pharmaceutical Industry Training Course

Drafting Commercial Contracts for the Pharmaceutical Industry

23-25 Nov 2022 - Online webinar

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Presented by James Agnew (bio)
and 15 more leading experts

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

23-24 Nov 2022 - Online webinar

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Presented by Salma Ismail (bio)
Makram Nehme (bio)

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The Patent Administrator Training Course

The Patent Administrator

24 Nov 2022 - Online webinar

This course will give you a comprehensive introduction to the role of the patent administrator

Presented by JoAnna Emery (bio)

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Common Technical Document Training Course

Common Technical Document

28-29 Nov 2022 - Online webinar

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

28-29 Nov 2022 - Online webinar

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

29-30 Nov 2022 - Online webinar

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

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IP (Intellectual Property) Due Diligence & Freedom to Operate in Practice Training Course

IP Due Diligence & Freedom to Operate in Practice

30 Nov 2022 - Online webinar

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Presented by Tim May (bio)
and 3 more leading experts

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December 2022 training courses

Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

1 Dec 2022 - Online webinar

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

Presented by Brian Kelly (bio)
David Richardson (bio)
Penny Viner (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

5-9 Dec 2022 - Online webinar

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Janette Benaddi (bio)

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Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

Working Through Veterinary Drug Development in the EU and USA

5-9 Dec 2022 - Online webinar

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

Presented by Julian Braidwood (bio)
David Petrick (bio)

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4-day International Commercial Contracts School Training Course

4-day International Commercial Contracts School

5-8 Dec 2022 - London

This specially designed four-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Presented by Mark Weston (bio)

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A Regulatory Update on Animal Feed and Feed Additives in the EU (European Union), USA and China Training Course

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

6-7 Dec 2022 - Online webinar

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

Presented by Elinor McCartney (bio)

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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

7-8 Dec 2022 - London

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

7-8 Dec 2022 - London

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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Patent Protection for Software-Related Inventions in Europe and the USA Training Course

Patent Protection for Software-Related Inventions in Europe and the USA

7 Dec 2022 - London

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Presented by Alan Boyd (bio)
Tim May (bio)
Andy Spurr (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

7-9 Dec 2022 - London

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

7-8 Dec 2022 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Business and Contract Law Training Course

Business and Contract Law

8-9 Dec 2022 - Online webinar

A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Presented by Arun Singh OBE (bio)

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Project Management for Pharma Professionals Training Course

Project Management for Pharma Professionals

8-9 Dec 2022 - London

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

Presented by Laura Brown (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

12 Dec 2022 - Online webinar

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

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3-day Drafting Commercial Contracts Training Course

3-day Drafting Commercial Contracts

12-14 Dec 2022 - Online webinar

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Presented by Mark Weston (bio)

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

12-13 Dec 2022 - Online webinar

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 6 more leading experts

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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

13-14 Dec 2022 - Online webinar

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Presented by Julian Braidwood (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

13 Dec 2022 - Online webinar

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Presented by Laura Brown (bio)

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The Role of an Effective HR Advisor Training Course

The Role of an Effective HR Advisor

13-14 Dec 2022 - Online webinar

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Presented by Jocelyn Hughes (bio)

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

14-15 Dec 2022 - London

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

14-15 Dec 2022 - London

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
Elizabeth Baker (bio)
David Jefferys (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

14 Dec 2022 - London

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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Liabilities, Damages and other Contentious Issues in International Commercial Agreements Training Course

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

14-15 Dec 2022 - London

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Presented by Arun Singh OBE (bio)

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Pharmacovigilance Training Course

Pharmacovigilance

14-16 Dec 2022 - Online webinar

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Presented by Glyn Belcher (bio)
and 6 more leading experts

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

14-15 Dec 2022 - Online webinar

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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US Patent Practice Training Course

US Patent Practice

15-16 Dec 2022 - Online webinar

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Presented by Nicole Reifman (bio)
James Suggs (bio)

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