How to take advantage of Early Access Programs new regulation for your innovative treatments in France?

https://www.youtube.com/watch?v=A6vJMw2fEmQ
Graphic design Computer program
March 17, 2022
40min
  • Early Access to market
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Thanks to early access programs, drugs are on average available in France 200 days before their first regulatory approval (FDA or EMA).​ In this context, early access programs can be extremely attractive for pharmaceutical companies developing life – transforming therapies.​

 

In July 2021, Early Access regulation has been largely reworked by the French Social Security reform.​

 

This webinar will focus on the early access regulatory changes in France since July 2021 reform and will present the major changes from the previous system. You will learn more about the benefits of Early Access programs and why having an experienced partner “Exploitant” in France is highly recommended.

 

Learning objectives:

 

  • Where are we 7 months after the new Early Regulation (Replacing ATU)?

  • Why Early Access (AP1/AP2) for the new innovative drugs in France is attractive and complex at the same time?

  • Why outsourcing your Early Access to a third party “Exploitant” in France is highly recommended?

 

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