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March 2021 training courses
Medical Writing for Medical Devices
3-4 Mar 2021 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
Veterinary Pharmaceutical Submissions in the EU
3-4 Mar 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)
Data Integrity and Document Management
5 Mar 2021 - 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)
Running Virtual Meetings
5 Mar 2021 - 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)
Presenting Virtually
8 Mar 2021 - 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)
Negotiating and Drafting IT Contracts
9-10 Mar 2021 - 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)
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
9-10 Mar 2021 - 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.
Business and Contract Law
9-10 Mar 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)
Regulatory Strategies for Orphan Drugs
10 Mar 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 Andrew Willis (bio)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
11-12 Mar 2021 - 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)
4-day International Commercial Contracts School
15-18 Mar 2021 - 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)
Strategic IP Planning
16-18 Mar 2021 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Understanding and Managing Competition Law Compliance
16 Mar 2021 - Online webinar
Learn how to navigate competition law and ensure compliance while maximising opportunities for your business
Advanced Pharmacovigilance
17-19 Mar 2021 - 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)
An Introduction to Pharmaceutical Packaging
17-18 Mar 2021 - 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)
Pharmaceutical Development of ATMPs
22-23 Mar 2021 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Risk Management for Pharma and Biopharma Professionals
22 Mar 2021 - 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)
Biosimilars
23-24 Mar 2021 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
NEW EVENT!
Presented by Andrew Willis (bio)
GCP and Clinical Research Update - Hot Inspection Topics
23 Mar 2021 - Online webinar
This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented
Presented by Laura Brown (bio)
Variations to Marketing Authorisations
25-26 Mar 2021 - 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 Andrew Willis (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
30 Mar 2021 - 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)
April 2021 training courses
Pharmaceutical Regulatory Affairs in Asia
7-9 Apr 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
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
12-13 Apr 2021 - 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)
Filing eCTD Submissions
13 Apr 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.
Biotechnology for the Non-Biotechnologist
14-16 Apr 2021 - 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 5 more leading experts
Mastering Powerful Conversations in a Fast-Changing World
14-15 Apr 2021 - Online webinar
A 2 day intensive skill based programme to help you engage and excel in powerful conversations in your organisation.
Pharmacovigilance Aspects of Licensing Agreements
15 Apr 2021 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Dealing With Difficult People
16 Apr 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)
EU Pharmaceutical Regulations & Strategy
19-20 Apr 2021 - Online webinar
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
Presented by Norah Lightowler (bio)
Advanced Regulatory Affairs for Medical Devices
20-21 Apr 2021 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Effective Technology Transfer
20-21 Apr 2021 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Introduction to Veterinary Pharmacovigilance
20-21 Apr 2021 - 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)
EPO Oppositions and Appeals - the Case Law and Workshop
21-22 Apr 2021 - 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 Leythem Wall (bio)
EU Clinical Trial Regulation: Overview and Implementation
22-23 Apr 2021 - 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)
An Essential Overview of Pharmacovigilance
26 Apr 2021 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Managing Vendor/CRO/CMO Oversight
26-27 Apr 2021 - Online webinar
Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource
Presented by Laura Brown (bio)
Practical Implementation of GCP in Veterinary Field Studies
27-28 Apr 2021 - 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.
The Role and Skills of a Valuable HR Assistant
28 Apr 2021 - 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)
Medical Device Software: Complying with the MDR & FDA Regulations
28-30 Apr 2021 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Drug/Device and Device/Drug Combinations in the EU and USA
28-29 Apr 2021 - Online webinar
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
May 2021 training courses
Signal Detection and Regulatory Expectations
4-5 May 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)
Development of Combination Products: Critical Interactions
5-6 May 2021 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
The New EU Animal Health Legislation for Veterinary Medicinal Products
5-6 May 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.
*INCLUDES: Interactive discussion sessions*
Presented by Julian Braidwood (bio)
Drafting Effective Pharmaceutical Patents
6-7 May 2021 - London
*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.
An Essential Overview of the Pharmaceutical and Biotech Industries
7 May 2021 - 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)
Medical Device Studies: Clinical Evidence
10-11 May 2021 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Influencing, Persuading and Negotiating Skills for International Lawyers
10-11 May 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)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
11-12 May 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.
Periodic Safety Update Reports for Veterinary Medicinal Products
11-12 May 2021 - Online webinar
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
*NEW EVENT!*
Presented by Declan O'Rourke (bio)
An Introduction to the Medical Device Regulation
12-14 May 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.
Litigation-Proofing and Proving your Patent Claims
12 May 2021 - Online webinar
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
The Pharma Mini MBA
12-14 May 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
Developing High Performance HR Business Partner and Consulting Skills
13-14 May 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)
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
13-14 May 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.
Pharmacovigilance QMS & Inspection Preparation
13-14 May 2021 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
13 May 2021 - 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.
Clean Communication
13 May 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)
Mental Resilience in a Home-working Environment
14 May 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)
Clinical Quality Management Systems
17-18 May 2021 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Biological Evaluation of Medical Devices
18-19 May 2021 - 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
The Role of an Effective HR Advisor
20-21 May 2021 - 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)
Drafting International Intellectual Property Agreements
20 May 2021 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
The Art of European Claim Drafting
20-21 May 2021 - Online webinar
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
Successful Medical Writing
24-26 May 2021 - 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.
An Introduction to the Design and Development of Medical Devices
24-25 May 2021 - 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)
Re-energising your Business and Financial Resilience out of the Covid 19 Crisis
24-25 May 2021 - Online webinar
Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.
Employment Law in Practice from Recruitment to Termination
25-26 May 2021 - 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)
Pharmaceutical Regulatory Affairs in Africa
26-27 May 2021 - Online webinar
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.
How to Improve Accuracy and Attention to Detail
28 May 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)
June 2021 training courses
Common Technical Document
2-3 Jun 2021 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Andrew Willis (bio)
Mastering Powerful Conversations in a Fast-Changing World
2-3 Jun 2021 - Online webinar
A 2 day intensive skill based programme to help you engage and excel in powerful conversations in your organisation.
Working Through Veterinary Drug Development in the EU and USA
7-10 Jun 2021 - London
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
8-9 Jun 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)
Reviewing and Negotiating Technology Transfer and Licensing Agreements
8-9 Jun 2021 - Online webinar
Providing key legal and commercial skills essential to secure a successful agreement.
*FULLY UPDATED PROGRAMME*
Presented by Michala Meiselles (bio)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
8 Jun 2021 - Online webinar
Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.
*NEW EVENT for 2020*
Presented by Toni Trevett (bio)
Drafting Commercial Contracts for the Pharmaceutical Industry
9-11 Jun 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
Positive Persuading and Influencing Skills for Pharma Professionals
9-10 Jun 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)
The Patent Administrator
9 Jun 2021 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Recruiting a High Performance Global Workforce Within the Law
10-11 Jun 2021 - Online webinar
*New for 2020!*
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.
The Role and Responsibilities of the Contracts Manager
10-11 Jun 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)
Drafting and Negotiating Clinical Trial Agreements
10 Jun 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
Drafting and Negotiating International Agency and Distribution Agreements
10-11 Jun 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)
US Patent Practice
10-11 Jun 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
Business and Contract Law
14-15 Jun 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)
3-day Drafting Commercial Contracts
15-17 Jun 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)
The Role of the Senior HR Manager
16-17 Jun 2021 - 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)
Registration of Animal Feed Additives in the EU
16-17 Jun 2021 - 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.
Advanced Drafting Techniques for Successful EPO Patent Applications
16 Jun 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)
Effective Defence of EPO Patent Applications
17 Jun 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)
Project Management for Pharma Professionals
17-18 Jun 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)
IP Due Diligence & Freedom to Operate in Practice
17 Jun 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.
Pharmacovigilance
21-23 Jun 2021 - 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
Strategic Thinking in the Pharma and Biopharma Industry
21-22 Jun 2021 - Online webinar
Strategy and strategic thinking skills in a covid-19 environment.
Presented by Laura Brown (bio)
The Mini MBA for In-house Lawyers
22-25 Jun 2021 - London
Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department
Dry Powder Inhalers
23-24 Jun 2021 - London
A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design
*FULLY UPDATED PROGRAMME*
Advanced Veterinary Pharmacovigilance
23-24 Jun 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)
Formal Requirements of the European Patent System
24-25 Jun 2021 - 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*
Pharmaceutical Regulatory Affairs in the Middle East
28-29 Jun 2021 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
A Practical Guide to Writing Risk Management Plans (RMPs)
28 Jun 2021 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
How to Write Effective SOPs
28 Jun 2021 - Online webinar
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Presented by Laura Brown (bio)
A Practical Guide to Producing and Maintaining the PSMF
29 Jun 2021 - 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)
CAPA (Corrective and Preventative Action)
29 Jun 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)
Medical Device Regulations in the Middle East and North Africa
30 Jun-1 Jul 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*
July 2021 training courses
The Medical Device Summer School - From Concept to CE Marking
5-9 Jul 2021 - London
*A practical five-day course with interactive workshops - now in its 17th successful year!*
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
Nick Baker (bio)
and 8 more leading experts
Clinical Trial Regulatory Requirements
5-6 Jul 2021 - 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)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
6-7 Jul 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.
Critical Thinking for Pharma and Biopharma Professionals
9 Jul 2021 - 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)
August 2021 training courses
Re-energising your Business and Financial Resilience out of the Covid 19 Crisis
24-25 Aug 2021 - Online webinar
Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.
September 2021 training courses
Project Management for Pharma Professionals
9-10 Sep 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)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
13-14 Sep 2021 - 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)
Managing Remote Teams
13 Sep 2021 - 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)
EPO Oppositions and Appeals - the Case Law and Workshop
13-14 Sep 2021 - London
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 Leythem Wall (bio)
FDA Approval Process for Medical Devices
13-14 Sep 2021 - 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)
Metered Dose Inhaler (MDI) Technology
13-14 Sep 2021 - London
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Running Virtual Meetings
14 Sep 2021 - 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)
EPO Oppositions and Appeals - the Case Law and Workshop
15-16 Sep 2021 - 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 Leythem Wall (bio)
FDA Approval Process for Medical Devices
15-16 Sep 2021 - 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)
Metered Dose Inhaler (MDI) Technology
15-16 Sep 2021 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Presenting Virtually
15 Sep 2021 - 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)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
15-16 Sep 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)
Drafting International R&D Collaboration and Joint Venture Agreements
16 Sep 2021 - 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)
An Essential Overview of the Pharmaceutical and Biotech Industries
16 Sep 2021 - London
Also on: 17 Sep 2021
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)
Drafting International R&D Collaboration and Joint Venture Agreements
17 Sep 2021 - 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)
The FDA Drug Approval Process
20-21 Sep 2021 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Presented by Andrew Willis (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
20-21 Sep 2021 - 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)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
20-21 Sep 2021 - 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)
Strategic IP Planning
21-23 Sep 2021 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Process Validation with Qualification
21-22 Sep 2021 - 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)
Risk Management for Pharma and Biopharma Professionals
21 Sep 2021 - London
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)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
22-23 Sep 2021 - 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)
Advanced Pharmacovigilance
22-24 Sep 2021 - 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)
Regulatory Strategies for Orphan Drugs
22 Sep 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 Andrew Willis (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
22-23 Sep 2021 - 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)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
22 Sep 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.
GCP and Clinical Research Update - Hot Inspection Topics
22 Sep 2021 - London
This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented
Presented by Laura Brown (bio)
Process Validation with Qualification
23-24 Sep 2021 - 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)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
23 Sep 2021 - London
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.
Effective Technical Writing & Editing
23 Sep 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)
Risk Management for Pharma and Biopharma Professionals
23 Sep 2021 - 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)
Effective Technical Writing & Editing
24 Sep 2021 - 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)
Patent Protection for Software-Related Inventions in Europe and the USA
24 Sep 2021 - 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.
GCP and Clinical Research Update - Hot Inspection Topics
24 Sep 2021 - Online webinar
This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented
Presented by Laura Brown (bio)
Regulatory Affairs for Support Staff
27-28 Sep 2021 - 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)
The FDA Drug Approval Process
27-28 Sep 2021 - London
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Presented by Andrew Willis (bio)
Advanced Regulatory Affairs for Medical Devices
28-29 Sep 2021 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Introduction to Pharmaceutical Packaging
28-29 Sep 2021 - 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)
Strategic IP Planning
28-30 Sep 2021 - London
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
28-29 Sep 2021 - London
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)
Biotechnology for the Non-Biotechnologist
29 Sep-1 Oct 2021 - 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 5 more leading experts
Regulatory Strategies for Orphan Drugs
29 Sep 2021 - London
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Andrew Willis (bio)
Advanced Pharmacovigilance
29 Sep-1 Oct 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)
Regulatory Affairs for Support Staff
29-30 Sep 2021 - 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)
Understanding and Managing Competition Law Compliance
30 Sep 2021 - Online webinar
Learn how to navigate competition law and ensure compliance while maximising opportunities for your business
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
30 Sep-1 Oct 2021 - 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)
An Introduction to Pharmaceutical Packaging
30 Sep-1 Oct 2021 - London
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)
Advanced Regulatory Affairs for Medical Devices
30 Sep-1 Oct 2021 - London
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
October 2021 training courses
Patent Protection for Software-Related Inventions in Europe and the USA
1 Oct 2021 - 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.
Understanding and Managing Competition Law Compliance
1 Oct 2021 - London
Learn how to navigate competition law and ensure compliance while maximising opportunities for your business
5-day International Commercial Contracts School
3-7 Oct 2021 - 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)
Pharmaceutical Development of ATMPs
4-5 Oct 2021 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
An Essential Overview of Pharmacovigilance
4 Oct 2021 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Successful Medical Writing
4-6 Oct 2021 - 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.
Data Integrity and Document Management
4 Oct 2021 - 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)
Effective Technology Transfer
5-6 Oct 2021 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Biosimilars
5-6 Oct 2021 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
NEW EVENT!
Presented by Andrew Willis (bio)
Patentability and State-of-the-Art Searching
5-6 Oct 2021 - Online webinar
A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.
An Essential Overview of Pharmacovigilance
5 Oct 2021 - London
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Data Integrity and Document Management
5 Oct 2021 - 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)
Negotiating and Drafting IT Contracts
6-7 Oct 2021 - 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)
The Role and Skills of a Valuable HR Assistant
6 Oct 2021 - 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)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
6-7 Oct 2021 - 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)
Biotechnology for the Non-Biotechnologist
6-8 Oct 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 5 more leading experts
The Role of an Effective HR Advisor
7-8 Oct 2021 - 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)
Managing and Leading an Effective In-House Legal Department
7-8 Oct 2021 - London
Two practical days to understand current best practice and generate creative, value-added solutions to your management challenges.
Freedom-to-Operate Searching
7 Oct 2021 - 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)
Variations to Marketing Authorisations
7-8 Oct 2021 - 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 Andrew Willis (bio)
Managing Vendor/CRO/CMO Oversight
7-8 Oct 2021 - Online webinar
Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource
Presented by Laura Brown (bio)
Effective Technology Transfer
7-8 Oct 2021 - London
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Pharmacovigilance Aspects of Licensing Agreements
7 Oct 2021 - London
Also on: 8 Oct 2021
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
5-day International Commercial Contracts School
10-14 Oct 2021 - 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)
Pharmaceutical Development of ATMPs
11-12 Oct 2021 - London
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Successful Medical Writing
11-13 Oct 2021 - 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.
Managing Vendor/CRO/CMO Oversight
11-12 Oct 2021 - London
Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource
Presented by Laura Brown (bio)
An Introduction to the Design and Development of Medical Devices
11-12 Oct 2021 - London
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
New Medical Device Regulation
12-13 Oct 2021 - 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.
Introduction to Veterinary Pharmacovigilance
12-13 Oct 2021 - 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)
Biosimilars
12-13 Oct 2021 - London
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
NEW EVENT!
Presented by Andrew Willis (bio)
Patentability and State-of-the-Art Searching
12-13 Oct 2021 - London
A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.
Employment Law in Practice from Recruitment to Termination
12-13 Oct 2021 - 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)
An Introduction to the Design and Development of Medical Devices
13-14 Oct 2021 - 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)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
13-14 Oct 2021 - 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)
Negotiating and Drafting IT Contracts
13-14 Oct 2021 - 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)
The Role and Skills of a Valuable HR Assistant
13 Oct 2021 - 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)
Employment Law in Practice from Recruitment to Termination
14-15 Oct 2021 - 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)
Freedom-to-Operate Searching
14 Oct 2021 - London
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)
The Role of an Effective HR Advisor
14-15 Oct 2021 - 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)
Variations to Marketing Authorisations
14-15 Oct 2021 - London
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 Andrew Willis (bio)
Introduction to Veterinary Pharmacovigilance
14-15 Oct 2021 - 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)
New Medical Device Regulation
14-15 Oct 2021 - 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.
Strategic Thinking in the Pharma and Biopharma Industry
14-15 Oct 2021 - Online webinar
Strategy and strategic thinking skills in a covid-19 environment.
Presented by Laura Brown (bio)
An Essential Overview of the Medical Device Industry
18 Oct 2021 - 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.
Filing eCTD Submissions
18 Oct 2021 - London
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
EU Clinical Trial Regulation: Overview and Implementation
18-19 Oct 2021 - 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)
EU Pharmaceutical Regulations & Strategy
18-19 Oct 2021 - London
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
Presented by Norah Lightowler (bio)
Medical Writing for Medical Devices
19-20 Oct 2021 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
Periodic Safety Update Reports for Veterinary Medicinal Products
19-20 Oct 2021 - Online webinar
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
*NEW EVENT!*
Presented by Declan O'Rourke (bio)
An Essential Overview of the Medical Device Industry
19 Oct 2021 - London
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.
Filing eCTD Submissions
19 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.
EU Clinical Trial Regulation: Overview and Implementation
20-21 Oct 2021 - 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)
Mastering Powerful Conversations in a Fast-Changing World
20-21 Oct 2021 - Online webinar
A 2 day intensive skill based programme to help you engage and excel in powerful conversations in your organisation.
EU Pharmaceutical Regulations & Strategy
21-22 Oct 2021 - Online webinar
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations
Presented by Norah Lightowler (bio)
Medical Writing for Medical Devices
21-22 Oct 2021 - London
How to produce quality regulatory documents including the clinical evaluation report (CER)
Periodic Safety Update Reports for Veterinary Medicinal Products
21-22 Oct 2021 - London
Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit
*NEW EVENT!*
Presented by Declan O'Rourke (bio)
Practical Implementation of GCP in Veterinary Field Studies
26-27 Oct 2021 - 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.
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)
Medical Device Software: Complying with the MDR & FDA Regulations
27-29 Oct 2021 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Pharmaceutical Packaging, Labelling and Artwork Origination
27-28 Oct 2021 - 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
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
28 Oct 2021 - Online webinar
Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.
*NEW EVENT for 2020*
Presented by Toni Trevett (bio)
Practical Implementation of GCP in Veterinary Field Studies
28-29 Oct 2021 - 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.
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)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
29 Oct 2021 - London
Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.
*NEW EVENT for 2020*
Presented by Toni Trevett (bio)
November 2021 training courses
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)
Recruiting a High Performance Global Workforce Within the Law
1-2 Nov 2021 - London
*New for 2020!*
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.
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)
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.
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.
*INCLUDES: Interactive discussion sessions*
Presented by Julian Braidwood (bio)
Recruiting a High Performance Global Workforce Within the Law
3-4 Nov 2021 - Online webinar
*New for 2020!*
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.
Drafting Effective Pharmaceutical Patents
3-4 Nov 2021 - London
*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.
Drafting Commercial Contracts
3-4 Nov 2021 - 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)
Medical Device Software: Complying with the MDR & FDA Regulations
3-5 Nov 2021 - London
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Signal Detection and Regulatory Expectations
3-4 Nov 2021 - 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)
Effectively Managing Legal Risk and Preserving Reputation
4-5 Nov 2021 - 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.
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
4-5 Nov 2021 - London
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.
The New EU Animal Health Legislation for Veterinary Medicinal Products
4-5 Nov 2021 - London
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.
*INCLUDES: Interactive discussion sessions*
Presented by Julian Braidwood (bio)
Drafting and Negotiating Clinical Trial Agreements
4 Nov 2021 - London
Also on: 5 Nov 2021
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
Medical Device Studies: Clinical Evidence
8-9 Nov 2021 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
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)
The Role of the Senior HR Manager
9-10 Nov 2021 - 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)
Development of Combination Products: Critical Interactions
9-10 Nov 2021 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Reviewing and Negotiating Technology Transfer and Licensing Agreements
9-10 Nov 2021 - Online webinar
Providing key legal and commercial skills essential to secure a successful agreement.
*FULLY UPDATED PROGRAMME*
Presented by Michala Meiselles (bio)
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)
The Art of European Claim Drafting
9-10 Nov 2021 - London
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
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.
Effective Defence of EPO Patent Applications
10 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)
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 Laura Brown (bio)
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)
Influencing, Persuading and Negotiating Skills for International Lawyers
10-11 Nov 2021 - 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)
Ownership and Control of Intellectual Property Rights
10 Nov 2021 - London
Also on: 11 Nov 2021
In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit
Presented by Mark Weston (bio)
Drafting and Negotiating International Agency and Distribution Agreements
11-12 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)
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.
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)
Advanced Drafting Techniques for Successful EPO Patent Applications
11 Nov 2021 - London
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)
Development of Combination Products: Critical Interactions
11-12 Nov 2021 - London
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
The Role of the Senior HR Manager
11-12 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)
Effective Defence of EPO Patent Applications
12 Nov 2021 - London
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)
Medical Device Studies: Clinical Evidence
15-16 Nov 2021 - London
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
The Pharma Mini MBA
15-17 Nov 2021 - 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)
Developing High Performance HR Business Partner and Consulting Skills
16-17 Nov 2021 - 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)
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)
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)
Reviewing and Negotiating Technology Transfer and Licensing Agreements
16-17 Nov 2021 - London
Providing key legal and commercial skills essential to secure a successful agreement.
*FULLY UPDATED PROGRAMME*
Presented by Michala Meiselles (bio)
Pharmacovigilance QMS & Inspection Preparation
16-17 Nov 2021 - London
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
An Introduction to the Medical Device Regulation
17-19 Nov 2021 - 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.
Pharmaceutical Regulatory Affairs in China
17-18 Nov 2021 - London
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
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)
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)
Drafting and Negotiating International Agency and Distribution Agreements
18-19 Nov 2021 - London
Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*
Presented by Michala Meiselles (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
18-19 Nov 2021 - London
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)
Drafting International Intellectual Property Agreements
18 Nov 2021 - London
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Formal Requirements of the European Patent System
18-19 Nov 2021 - 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*
Drafting International Intellectual Property Agreements
19 Nov 2021 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Advanced Veterinary Pharmacovigilance
22-23 Nov 2021 - 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)
Technical Documentation to Comply with the MDR and IVDR
22-23 Nov 2021 - London
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.
Critical Thinking for Pharma and Biopharma Professionals
22 Nov 2021 - 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)
Biological Evaluation of Medical Devices
23-24 Nov 2021 - 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
The Mini MBA for In-house Lawyers
23-26 Nov 2021 - London
Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department
The Role and Responsibilities of the Contracts Manager
23-24 Nov 2021 - 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)
Drafting Commercial Contracts for the Pharmaceutical Industry
24-26 Nov 2021 - 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
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.
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)
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)
Technical Documentation to Comply with the MDR and IVDR
24-25 Nov 2021 - 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.
Re-energising your Business and Financial Resilience out of the Covid 19 Crisis
24-25 Nov 2021 - Online webinar
Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.
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)
Formal Requirements of the European Patent System
25-26 Nov 2021 - 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*
Clinical Quality Management Systems
25-26 Nov 2021 - London
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
The Patent Administrator
25 Nov 2021 - London
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
29-30 Nov 2021 - 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)
Common Technical Document
29-30 Nov 2021 - London
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Andrew Willis (bio)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
29-30 Nov 2021 - London
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.
US Patent Practice
29-30 Nov 2021 - 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
Business and Contract Law
30 Nov-1 Dec 2021 - 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)
IP Due Diligence & Freedom to Operate in Practice
30 Nov 2021 - 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.
December 2021 training courses
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)
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.
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 Andrew Willis (bio)
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
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)
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)
How to Write Effective SOPs
2 Dec 2021 - Online webinar
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Presented by Laura Brown (bio)
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)
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.
Pharmacovigilance
6-8 Dec 2021 - 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 7 more leading experts
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)
How to Write Effective SOPs
6 Dec 2021 - London
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Presented by Laura Brown (bio)
CAPA (Corrective and Preventative Action)
7 Dec 2021 - 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)
Veterinary Pharmaceutical Submissions in the EU
8-9 Dec 2021 - London
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)
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)
Borderlines between Medicines and Food
9 Dec 2021 - London
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 Penny Viner (bio)
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
9-10 Dec 2021 - London
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)
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 Penny Viner (bio)
Project Management for Pharma Professionals
13-14 Dec 2021 - 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)