Live Webinar: Regulatory pathway and agency interaction: The EU vs. the US


The introduction of a new medicinal product to the US and European market follows a complex process that may extend many years from the initial discovery through to the FDA and EMA approval and market launch. There are many factors during the product development that impact the success drug approval and launch, and a thorough understanding of the US and EU regulations and requirements is often underrated. The drug development process is becoming increasingly specialized and the regulatory pathway that works for one program may not work or be applied to another program for the same indication and this also applies to the regions considered.

In this webinar, we talk about:

  1. What are the similarities and differences between the US and European health agencies in terms of review team, meeting opportunities, clinical trial submissions (IND vs. CTA)
  2. When and how to interact with the FDA and EMA?
  3. What are the FDA and EMA’s expedited programs?


Lise Merlay-Barbin, Ph.D.

Director, Regulatory Science, Voisin Consulting Life Sciences 

Lise has over 10 years of experience in regulatory strategy and operation, managing projects from early stages of development to late clinical development phases and up to preparation of MAA/BLA/NDA, both in Europe & the US. She has hand-on experience in the preparation, coordination and submission of centralized MAAs, NDAs, and BLAs. She is an expert in European Scientific Advice procedures including the authoring of briefing documents, in ODD applications, as well as in PIP.


Michael Day, Ph.D.

Senior Director, Regulatory Science, Voisin Consulting Life Sciences 

Michael has over 20 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs, and NDAs. He provides both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.

Live date: June 16th 2022 at 13:00 CET (19:00 Chinese time)

Register now!

EC Innovations Life Sciences Division

Scroll to Top