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Session 4: Early Access Paths in Europe
Session Chair(s)
Michela Gabaldo, PharmD, MSc
VP ATMP Global Regulatory Affairs, Evotec, Italy
Topics covered in this session include:
- How unified is the approach to early access?
- Available Early Access Schemes
- Challenges with ATMPs
- Return on Investment issues
- Chronic vs. one-time use drugs
- Outcome based agreements
- Compassionate use vs. Early Access Schemes
Speaker(s)
Sandra Petraglia, MD, PhD
Head of Pre Authorisation Department, AIFA - Agenzia Italiana Del Farmaco, Italy
Oswald Bentinck
Vice President, Global Head of Value & Access, Rocket Pharmaceuticals, Inc., United States
Industry Perspective: Available Early Access Schemes
Nicolas Koebel
Chief Executive Officer of EpilepsyGTx Limited, EpilepsyGTx Limited, United Kingdom
Case Study: Early Access Paths working for ATMPs
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