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Session 1: Development of Advanced Therapy Medicinal Products (ATMPs) – Challenges and Opportunities from the Industry and Authority Perspective
Session Chair(s)
Maren von Fritschen, PharmD
Head EU Regulatory Policy
Moderna, Netherlands
Session 1: Development of Advanced Therapy Medicinal Products (ATMPs) – Challenges and Opportunities from the Industry and Authority Perspective
Speaker(s)
Industry’s Perspective on ATMP Development
Andrea Braun-Scherhag, DrSc, PhD
Autolus, Switzerland
Vice President, Global Head Regulatory Affairs
EMA’s perspective on ATMP development
Ana Hidalgo-Simon, DrMed
European Medicines Agency, Netherlands
Head of Advanced Therapies
Regulatory Assessor’s perspective on ATMP development
Ilona Reischl, PhD, MPharm
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
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