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