Preconference Workshop: Drug Development in the EU: Regulatory Standards, Supports, and New Approaches

Preconference Workshop Description: Successful and meaningful interactions with regulatory authorities are at the core of drug development. These include discussions on the design and approval of clinical trials, the effective use of scientific advice, leveraging regulatory support programs, understanding the intricacies of developing programs for orphan and paediatric products, and navigating approval and post-marketing activities/commitments.

Modern drug development is usually a global undertaking, and as such, it is in the interest of all stakeholders to have as much alignment as possible in the different jurisdictions. Join us for this insightful workshop, where you will recognize how European regulators support drug development, marketing authorization, and market surveillance. We will address regulatory processes and explain the dual role of European regulators as gatekeepers and enablers.

We will discuss established and new European regulatory approaches. Furthermore, we will talk about how the selected topics are handled in the EU and the US so that you can better appreciate the differences and commonalities between European regulators and the US FDA. We will also have time dedicated to addressing your questions and discussing potential practical scenarios.

Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Breakfast for Preconference Workshop Attendees

8:30 – 8:35 AM: Introduction to the workshop

8:35 – 9:20 AM: Introduction to the Legislative Background of EU Regulation of Drugs + US Perspective

9:20 – 10:00 AM: Regulatory Interactions in Scientific Advice, Joint Advice EMA-HTA/FDA + US Perspective

10:00 – 10:30 AM:  Moderated Q&A Session on the above Topics (EU Legislation, Scientific Advice)

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Attendees

11:00 – 11:30 AM:  Challenges in Pediatric Development + US Perspective

11:30 – 12:00 AM:  How to get and keep the Orphan Designation + US Perspective

12:00 – 12:30 PM:  Moderated Q&A Session on the above Topics (Pediatric Medicines, Orphan Designation)

12:30 – 1:30 PM: Lunch for Preconference Workshop Attendees

1:30 – 2:00 PM:  PRIME in EU + US Perspective

2:00 – 2:30 PM:  Different Pathways to Marketing Authorization including Early Access + US Perspective

2:30 – 3:00 PM:  Moderated Q&A Session on the above Topics (PRIME, Marketing Authorization)

3:00 – 3:15 PM: Break for Preconference Workshop Attendees

3:15 – 3:45 PM:  Use of Real-World Evidence pre- and post-authorization + US Perspective

3:45 – 4:00 PM:  Moderated Q&A Session on the above Topic (Real-World Data)

4:00 PM: Adjourn (all workshops must adjourn for the day)