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Session 2: Early Interaction with Regulators, Scientific Advice and PRIME Scheme
Session Chair(s)
Maren von Fritschen, PharmD
Drug Development and Regulatory Affairs - MSC Course, University of Applied Sciences, Germany
Topics explored in this Session:
- How to meet patients’ expectations for early access to ATMPs
- PRIME scheme: achievements and future improvements
- How to foster global expedited pathways for ATMPs - industry perspective
Speaker(s)
Jordi Llinares Garcia, MS
Head of Research and Innovation, European Medicines Agency, Netherlands
PRIME achievements and future improvements
Jacquelyn Awigena-Cook, MSc
Director, Global Regulatory Policy & Intelligence, Bristol Myers Squibb, United Kingdom
How to foster global expedited pathways for ATMPs - industry perspective
Sam Ringle, PhD
EU Regulatory Affairs Manager, CSL Behring Innovation Gmbh, Germany
Experiences from Early Interactions with Regulators
Bettina Ziegele, MA
Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer, , Division Major Policy Issues, Paul-Ehrlich-Institut, Germany
Simultaneous National Scientific Advice (SNSA) Pilot – first experiences and the way forward
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