Course description
Clinical trials 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 in order to ensure a successful outcome for the pharmaceutical company undertaking the project.
Presented by Francisco Javier García Pérez, a senior associate at Uría Menéndez, this virtual classroom seminar will explore everything you need to know in order to effectively draft and negotiate clinical trial agreements.
Upcoming start dates
Outcome / Qualification etc.
Training Course Content
Introduction
Clinical trials are an essential part of the authorisation process of any drug intended for human or animal 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 in order 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 outline of the practice, different types, and procedural steps of clinical trials
- The main differences between clinical trials in the medicine and in the veterinarian fields
- Main data protection considerations in clinical trials: the challenge of multijurisdictional projects and the re-use of data
- Main IP considerations arising from clinical trials
- How to effectively draft and negotiate clinical trial agreements
Expenses
MBL Seminars Limited
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