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Overcoming Barriers to ATMPs Through Collaboration and Regulatory Reliance
Session Chair(s)
Michela Gabaldo, PHARMD, MSC
VP ATMP Global Regulatory Affairs, Evotec, Italy
This session aims to discuss the need to converge on the definitions and classification of ATMPs in order to foster reliance and/or recognition approaches to enable patients’ access to ATMPs.
Learning Objective : • Present regulatory landscape for ATMPs (show comparisons between EU, US, Global inlc. Legal frameworks and classifications) • Draw on examples of access-limiting requirements • Discuss and highlight recommendations to facilitate regulatory convergence and reliance approaches for ATMPs
Speaker(s)
Kowid Ho, PHARMD
Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Overcoming Barriers to Advanced Therapy Medicinal Products (ATMPs) Through Collaboration and Regulatory Reliance
Lina Koufokotsiou
Policy Officer, European Commission - DG SANTE, Belgium
Overcoming barriers to ATMPs: How the Revision of the EU Pharma Legislation will Boost ATMPs?
Caroline Pothet, PHARMD, RPH, RAC
Head of advanced therapies and haemato-oncology, European Medicines Agency, Netherlands
Current and Future Elements of the EU Framework from a Regulator’s Perspective
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