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Session 3: Hospital Exemption and Implications for Drug Development
Session Chair(s)
Maren von Fritschen, PharmD
Drug Development and Regulatory Affairs - MSC Course
University of Applied Sciences, Germany
Legal & political background for the hospital exemption Criteria to obtain a hospital exemption Different implementation & interpretation in the EU Member States Reimbursement implications ? Commercial impact for fully authorized ATMPs
Speaker(s)
Hospital Exemption for ATMPs from the Regulator’s Perspective
Jurgen Scherer
Paul-Erlich-Institut (PEI), Germany
Head of Section, Advanced Therapy Medicinal Products, Tissue Preparations
Learnings from the Hospital Exemption in Different National EU Member States from a Manufacturer’s Perspective Plus Future Challenges
Pietro Sternini
Atara Biotherapeutics, Switzerland
Head of Market Access Europe