1st Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU

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Session 3: Hospital Exemption and Implications for Drug Development

Session Chair(s)

Maren von Fritschen, PharmD

Head EU Regulatory Policy

Moderna, Netherlands

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

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