MBA Strategic Thinking for Pharma and Biopharma

6-7 Sep 2021 - 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.

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

6-7 Sep 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.

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

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

10 Sep 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)

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.

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.

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.

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.

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.

Metered Dose Inhaler (MDI) Technology

15-16 Sep 2021 - Online webinar

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

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.

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.

An Essential Overview of the Pharmaceutical and Biotech Industries

17 Sep 2021 - Online webinar

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

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

Best Practice for Writing Effective SOPs

20 Sep 2021 - London

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

Strategic IP Planning

21-23 Sep 2021 - Online webinar

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

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.

CAPA (Corrective and Preventative Action)

21 Sep 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.

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.

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.

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.

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.

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.

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.

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 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

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.

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

27-28 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.

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.

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.

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

29-30 Sep 2021 - Online webinar

Practical guidance on borderline Issues and combination products

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

5-day International Commercial Contracts School

4-8 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.

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.

Effective Technology Transfer

5-6 Oct 2021 - Online webinar

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

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.

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.

The Role and Skills of a Valuable HR Assistant

6 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 .

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.

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.

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

The Role of an Effective HR Advisor

7-8 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.

Pharmacovigilance Aspects of Licensing Agreements

8 Oct 2021 - Online webinar

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

New Medical Device Regulation

11-12 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.

An Introduction to the Design and Development of Medical Devices

11-12 Oct 2021 - Online webinar

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

Root Cause Analysis and Critical Thinking

11 Oct 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

A Practical Guide to Writing Risk Management Plans (RMPs)

11 Oct 2021 - London

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

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*

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

12 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.

A Practical Guide to Producing and Maintaining the PSMF

12 Oct 2021 - 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.

Biosimilars

13-14 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!

Pharmaceutical Regulatory Affairs in Asia

13-15 Oct 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

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.

Variations to Marketing Authorisations

14-15 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.

Pharmaceutical Development of ATMPs

18-19 Oct 2021 - Online webinar

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

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.

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

Medical Writing for Medical Devices

19-20 Oct 2021 - Online webinar

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

An Essential Overview of Pharmacovigilance

19 Oct 2021 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Cyber Security for Medical Devices

20-21 Oct 2021 - Online webinar

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.

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.

The impact of the end of the Brexit transition period will be discussed.

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.

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.

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.

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

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

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*

Recruiting a High Performance Global Workforce Within the Law

3-4 Nov 2021 - 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.

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.

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.

Development of Combination Products: Critical Interactions

4-5 Nov 2021 - Online webinar

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

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

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!*

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*

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.

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.

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

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.

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

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.

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.

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.

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

Effectively Managing Legal Risk and Preserving Reputation

17-18 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.

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.

Clinical Quality Management Systems

18-19 Nov 2021 - Online webinar

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

Formal Requirements of the European Patent System

18-19 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*

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.

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

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*

Litigation-Proofing and Proving your Patent Claims

23 Nov 2021 - Online webinar

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

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.

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

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

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.

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!*

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.

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*

Pharmaceutical Regulatory Affairs in Africa

29-30 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

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

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.

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

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.

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.

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.

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

1-2 Dec 2021 - London

Practical guidance on borderline Issues and combination products

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.

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.

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.

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.

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 - Online webinar

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

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.

Managing stress & anxiety

6 Dec 2021 - Online webinar

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

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.

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.

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

6 Dec 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.

The Medical Device School - From Concept to CE Marking

6-10 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.

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

Project Management for Pharma Professionals

9-10 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

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*

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

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.

Registration of Animal Feed Additives in the EU

14-15 Dec 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.

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

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

Effective Technology Transfer

11-12 Jan 2022 - London

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

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.

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.

NEW EVENT!

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.

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.

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.

Managing Vendor/CRO/CMO Oversight

17-18 Jan 2022 - 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

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.

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.

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.

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 .

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.

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.

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

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

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

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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

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*

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!*

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

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

The Patent Administrator

25 Feb 2022 - London

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

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

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.

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.

Advanced Regulatory Affairs for Medical Devices

1-2 Mar 2022 - Online webinar

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

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.

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.

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.

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

Drafting International R&D Collaboration and Joint Venture Agreements

7 Mar 2022 - Online webinar

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

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.

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.

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.

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.

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

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

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

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.

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.

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.

Injectable Drug Delivery

15-16 Mar 2022 - Online webinar

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

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.

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.

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.

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.

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 Planning

21-23 Mar 2022 - Online webinar

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

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.

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

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

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.

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.

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.

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.

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.

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)

Metered Dose Inhaler (MDI) Technology

31 Mar-1 Apr 2022 - Online webinar

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

MBA Strategic Thinking for Pharma and Biopharma

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.

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.

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.

NEW EVENT!

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.

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.

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

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.

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.

Effective Technology Transfer

6-7 Apr 2022 - Online webinar

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

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

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.

An Essential Overview of Pharmacovigilance

8 Apr 2022 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

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.

EU Pharmaceutical Regulations & Strategy

11-12 Apr 2022 - Online webinar

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

The impact of the end of the Brexit transition period will be discussed.

Managing Vendor/CRO/CMO Oversight

11-12 Apr 2022 - 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

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.

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.

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.

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

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

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.

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

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.

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*

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.

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.

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.

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.

Cyber Security for Medical Devices

28-29 Apr 2022 - Online webinar

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.

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.

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*

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

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

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.

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

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.

Biological Evaluation of Medical Devices

5-6 May 2022 - Online webinar

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

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

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

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*

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*

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.

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.

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.

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*

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!*

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.

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

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

The Patent Administrator

13 May 2022 - Online webinar

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

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

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.

*INCLUDES: Interactive discussion sessions*

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.

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.

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

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

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

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.

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!*

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.

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.

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.

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.

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.

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.

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.

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 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.

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

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.

Clinical Quality Management Systems

26-27 May 2022 - Online webinar

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

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.

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

1-2 Jun 2022 - London

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

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.

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.

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

7-8 Jun 2022 - London

Practical guidance on borderline Issues and combination products

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.

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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

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

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.

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.

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.

Metered Dose Inhaler (MDI) Technology

20-21 Jun 2022 - London

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

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

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

The Role of an Effective HR Advisor

21-22 Jun 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.

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.

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.

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.

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.

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.

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.

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.

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.

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*

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

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.

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.

NEW EVENT!

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

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.

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.

Effective Technology Transfer

4-5 Jul 2022 - London

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

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

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.

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.

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*

Medical Writing for Medical Devices

5-6 Jul 2022 - London

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

EU Pharmaceutical Regulations & Strategy

5-6 Jul 2022 - London

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

The impact of the end of the Brexit transition period will be discussed.

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.

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.

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 .

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.

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.

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.

Managing Vendor/CRO/CMO Oversight

11-12 Jul 2022 - 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

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.

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.

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.

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

Practical Implementation of GCP in Veterinary Field Studies

13-14 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.

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.

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

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.

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.

Drafting and Negotiating Clinical Trial Agreements

1 Aug 2022 - London