Drafting & Negotiating Clinical Trial Agreements - Key IP & Data Protection Considerations

Introduction

Clinical trials are an essential part of the authorisation process of any drug intended for human use.

They are heavily regulated to ensure, amongst other elements, the robustness of their results as well as the safety of participants and of the tested drugs.

Clinical trials pose substantial challenges in the fields of intellectual property and data protection, which must be overcome to ensure a successful outcome for the pharmaceutical company undertaking the project.

What You Will Learn

This live and interactive session will cover the following:

• An overview of the regulatory framework governing clinical trials, with a particular focus on the European Union
• The main challenges arising from the conduct of clinical trials
• Key mechanisms for the protection of intellectual property in clinical trials
• Main data protection considerations in clinical trials, including the challenges of multijurisdictional projects and the re-use of data
• Tips on how to effectively draft and negotiate clinical trial agreements

Recording of live sessions: Soon after the Learn Live session has taken place you will be able to go back and access the recording - should you wish to revisit the material discussed.