Talk CMC & Product Quality track
S0202 - Opportunities from Regulatory Reliance on Post-Approval CMC Changes and GMP Inspections
Wed, Mar 19, 2025 · 3:00–4:10 PM CET Kairo 1-2 Room, Congress Center Basel
About this session
The session will focus on the current status of reliance and recognition globally. We will discuss reducing PACs, transformation of LCM and emerging GMPs in the context of submissions and regulatory inspections.
Programme:
- 3. Opportunities for Convergence and Reliance for PACs — Isabelle Colmagne-Poulard
- 1. International collaborations to support Reliance — Brendan Cuddy
- 5. Emerging GMPs in the Context of Submissions and Regulatory Inspections — Stephan Roenninger
- Panel Discussion — Marie Valentin, Günter Waxenecker
- 2. Europe at the Cutting Edge: The Transformation of Lifecycle Management — Monica Perea-Velez
- 0. Setting the Scene — Evdokia Korakianiti
- 4. A Practical Approach to Post Approval Change Processes to Mitigate Shortage Risks to Global Supplies — Angelika Joos
Speakers
-
Head of the Austrian Medicines and Medical Devices Agency · Austrian Medicines and Medical Devices Agency (AGES)
Panelist
-
Independent consultant · CRP International Strategy Consulting
Speaker
-
Head of International Global Regulatory & Scientific Policy · Merck KGaA
Speaker
