戻る Agenda
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)
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,