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Session 2: Parallel Scientific Advice
Session Chair(s)
Anja Schiel, PhD
Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
Norwegian Medicines 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)
The Regulatory Perspective
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
HTA Body Perspective
Anja Schiel, PhD
Norwegian Medicines Agency (NoMA), Norway
Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
The Industry Perspective, Pros and Cons
Judith Creba, PhD
Novartis Pharma AG, Switzerland
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
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