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Session 2: Parallel Scientific Advice
Session Chair(s)
Anja Schiel, PHD
Special Advisor, Lead Methodologist/Statistician; NOMA, Norwegian Medical Products Agency (NOMA), Norway
In this session, the different Stakeholder experiences with Parallel Scientific Advice will be presented. The Speakers will reflect on their learnings as well as discuss how such learnings can translate into improvements that can be proposed for the future. This session also sets the scene for the SA role-play in session 3 where participants are encouraged to take different Stakeholder perspectives when discussing different theoretical products.
Speaker(s)
Michael Berntgen, PHD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Regulatory Perspective
Anja Schiel, PHD
Special Advisor, Lead Methodologist/Statistician; NOMA, Norwegian Medical Products Agency (NOMA), Norway
HTA Body Perspective
Judith Creba, PHD
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland
The Industry Perspective, Pros and Cons
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