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

Description: Successful and meaningful interactions with regulatory authorities are at the core of drug development. These include regulatory aspects of drug product manufacturing, engagements 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.

Proposed Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Networking Breakfast & Welcome for Workshops Registrants

8:30 AM: All Preconference Workshops Begins

8:30 – 8:35 AM: Introduction to the workshop (Speaker(s): Andrea Laslop)

8:35 – 9:15 AM: Introduction to the Legislative Background of EU Regulation of Drugs + US Perspective (Speaker(s): John Joseph Borg & Daniela Drago)

9:15 – 9:55 AM: Implementation of EU GMP Annex I – EU + US perspective (Speaker(s): Sue Liu)

9:55 – 10:15 AM: Moderated Q&A Session on the above Topics (EU Legislation, EU GMP Annex I) (Speaker(s): All speakers as applicable and workshop participants)

10:15 – 10:30 AM: PRIME in EU + US perspective (Speaker(s): Andrea Laslop & Daniela Drago)

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

11:00 – 11:30 AM: Regulatory Interactions in Scientific Advice, Joint Advice EMA-HTA/FDA + US perspective (Speaker(s): Andrea Laslop & Daniela Drago)

11:30 – 12:00 AM: How to get and keep the Orphan Designation + US Perspective (Speaker(s): Karl-Heinz Huemer & Daniela Drago)

12:00 – 12:30 PM: Moderated Q&A Session on the above Topics (PRIME, Scientific Advice, Orphan Designation) (Speaker(s): All speakers as applicable and workshop participants)

12:30 – 1:30 PM: Lunch & Networking for Preconference Workshop Registrants

1:30 – 2:05 PM: Challenges in Pediatric Development + US Perspective (Speaker(s): Karl-Heinz Huemer + Daniela Drago)

2:05 – 2:40 PM: Different Pathways to Marketing Authorization including Early Access + US Perspective (Speaker(s): Andrea Laslop
+ Daniela Drago)

2:40 – 3:00 PM: Moderated Q&A Session on the above Topics (Pediatric Medicines, Marketing Authorization) (Speaker(s): All speakers as applicable and workshop participants)

3:00 – 3:15 PM: Refreshment Break for Preconference Workshop Registrants

3:15 – 3:50 PM: Use of Real-World Evidence pre- and post-authorization + US Perspective (Speaker(s): Sabine Haubenreisser + Daniela Drago)

3:50 – 4:00 PM: Moderated Q&A Session on the above Topic (Real-World Data) (Speaker(s): All speakers as applicable and workshop participants)

4:00 PM: All Preconference Workshops Adjourn for Day