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Session 1: Regulatory Requirements, Considerations and Challenges
Session Chair(s)
Maren von Fritschen, PharmD
Head EU Regulatory Policy
Moderna, Netherlands
Topics explored in this Session:
- Regulatory challenges for ATMP development – regulators and industry perspective.
- ATMP development along the value chain.
Speaker(s)
Regulatory Considerations for ATMPs Development: Looking Ahead
Ana Hidalgo-Simon, DrMed
European Medicines Agency, Netherlands
Head of Advanced Therapies
Regulatory Challenges in the Development of Innovative ATMPs
Marco Gregorini, PhD, MBA
Vertex Pharmaceuticals, United Kingdom
Senior Director, Regulatory Strategy
Learnings from ATMPs Development and Future Considerations
Miriam Fuchs, PhD
Novartis, Switzerland
Global Therapeutic Area Lead, Reg. Affairs, Oncology Cell & Gene Therapies
Current Challenges of ATMPs Development from an Orphan Perspective
Andrea Braun-Scherhag, DrSc, PhD
Autolus, Switzerland
Vice President, Global Head Regulatory Affairs
Contributing Panelist
Laura Liebers
Vertex Pharmaceuticals, United Kingdom
Regulatory Regulatory Policy and Intelligence Director
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