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Session 1- Submission Predictability in Initial Marketing Authorisation: A Regulatory Authority Perspective
Session Chair(s)
Francesca Day
Human Medicines Division, Head of Therapeutic Areas Department (H-TA), European Medicines Agency , Netherlands
This session explores the issue from the viewpoint of regulatory authorities. EMA will present statistical insights to define the scope of the problem, followed by the MEB’s perspective on common challenges and their impact. The session concludes with real-world case studies illustrating how regulators are working to reduce delays and improve submission predictability through increased transparency, guidance, and collaboration.
Speaker(s)
Francesca Day
Human Medicines Division, Head of Therapeutic Areas Department (H-TA), European Medicines Agency , Netherlands
Enrico Tognana, PHD
Senior Business Intelligence Specialist, Regulatory and Innovation Task Force, European Medicines Agency, Netherlands
Problem statement: EMA statistics on submission predictability
Menno Van Der Elst, PHARMD, PHD
Head of EU Committees Department, MEB, Netherlands
Views, concerns, and experience from MEB
Guenter Waxenecker
Head of the Austrian Medicines and Medical Devices Agency, Austrian Medicines and Medical Devices Agency (AGES), Austria
Predictability Matters: Tackling Delays and Uncertainty in Regulatory Submissions with Case Studies
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