About this SESSION

This session will provide an in-depth overview of the French early access system, detailing both the standard regulations and the exceptions within it. It will cover the timelines, criteria, and processes involved in the "Accès Précoce" (AAP) and "Accès Compassionnel" (AAC) programs, as well as the complexities of navigating this system. The session will offer valuable insights into how to effectively manage early access in France, including data collection, regulatory considerations, and successful program implementation.

What we'll cover

  • The timelines and distinct routes of the French early access system, including AAP (Pre-MA and Post-MA) and AAC.
  • Mandatory criteria for both AAP and AAC programs.
  • The complexities of the early access process, including supply, data collection, and regulatory requirements.
  • Exceptions to the standard rules, such as products with no marketing plan in France, EMA-approved products with delayed marketing, and products with a refused AP1 dossier.
  • Strategies for simplifying the process and ensuring smooth program completion.

Meet the speakers

Natalie Caizergues – Senior Medical Affairs Manager

Nathalie Caizergues joined iQone in 2012 (prior to the acquisition of the company by Clinigen) as an MSL in France in haematology. She moved to a role of MSL Manager Europe in 2015, specifically in charge of EAPs in Europe (Spain, Italy, Germany, Belgium and Luxembourg) and of the ATU in France. Nathalie is now EU Medical Affairs Manager and in charge of Early Access in France for Clinigen Healthcare France. In this role, she supports clients with their early access strategy in France; Accès Compassionnel with or without PUT, and the Accès Précoce process. Previously, Nathalie worked as an MSL for Amgen, Bayer and Novartis. She is a biologist by training.

Who should attend

  • Pharmaceutical professionals involved in market access and regulatory affairs.
  • Individuals seeking to understand the French early access system.
  • Professionals working with early access programs in Europe.
  • Anyone interested in the specifics of navigating early access in France.

Register to attend

Join us live or watch on demand after the event.

Register 

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