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