With 28 member states and associated countries, initiating a clinical trial in the EU is perceived by many in the industry to be a daunting challenge. Upcoming changes in the regulations will change the clinical trial approval process, and make it much easier for pharma and biotech companies.
Objectives of the session:
- Understand the current scenario for including European site(s) in your clinical trials;
- Anticipate and plan for future changes and their impact on the overall approval process and timeline.
Delphine Decker, Senior Director Digital & Internal Communication
As Senior Director, Digital & Internal Communication (SDDIC), and based on my 14 years of experience in the company, she supports the VCLS group in its digital transformation and for its internal communication.The ultimate objectives are the client satisfaction and the development and well-being of the VCLS staff.
Cécile Henrot, Associate Director in clinical trials.
As a project manager and advisor, she oversees the studies from a regulatory point of view and manages the submissions to European competent authorities, ethics committees and other regulatory bodies as appropriate, such as regional authorities and data protection committees.