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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)
Jurgen Scherer
Head of Section, Advanced Therapy Medicinal Products, Tissue Preparations, Paul-Erlich-Institut (PEI), Germany
Hospital Exemption for ATMPs from the Regulator’s Perspective
Pietro Sternini
Head of Market Access Europe, Atara Biotherapeutics, Switzerland
Learnings from the Hospital Exemption in Different National EU Member States from a Manufacturer’s Perspective Plus Future Challenges
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