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

March 17, 2022
  • Early Access to market

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?


Access the Full Webinar and the slide deck

    By sending this form, I agree that my personal data will be saved and processed according to data protection regulations and will be used only for commercial and marketing purposes only.

    Learn more

    BlueReg undertakes to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 applicable as from 25 May 2018 (hereinafter, "the General Data Protection Regulations" or GPDR) and the national laws resulting therefrom.
    Any inquiries, correction or declaration of event related to personal data processed should be sent to: GDPR data request

    GDPR data request

    Thank you! You can watch the webinar now.

    Download your document