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Pharmaceuticals

From Confusion to Clarity: Decoding US and European Regulatory Meetings During Development, for Optimal Results

Thursday, May 15, 2025
14:30 - 15:30 CEST
Location: The Arc (level 3)
Learning Level: Intermediate
Description:

For EU:
Getting input from the regulators during various stages of the drug development process is a must. However, in the European Union (EU) there are now 7 types of scientific advice (SA) available for Sponsors:
National SA/ National Joint SA with reimbursement agencies/Simultaneous National SA (SNSA)/EMA CHMP SA/EMA CHMP SA in parallel to a Joint Scientific Consultation with the HTA Coordination Group (HTACG)/Joint CHMP and Clinical Trials Coordination Group SA /Joint EMA/FDA SA.
In this session, we will discuss what are the most relevant situations and appropriate questions as well as timing considerations for each type of SA

For US:
The session will summarize the different meeting types with FDA during development and will provide an opportunity to discuss the best timing for different FDA meetings, including the minimal data desired for obtaining the maximum benefit from the FDA input related to the product development stage.

Learning Objectives:

  • attendees will get an in-depth look at different types of SA in EU as well as will gain practical experience on how to best plan the strategy for interactions with the European regulators at the different time points of their drug development.
  • participants will be familiar with different meeting types available for sponsors seeking FDA input.
  • participants will be able to plan a strategy for the data required at the time of the meeting to maximize the value for further product development.
  • participants will be familiar with the updates in the new FDA meeting guideline for PDUFA products