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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)
Overcoming Barriers to Advanced Therapy Medicinal Products (ATMPs) Through Collaboration and Regulatory Reliance
Kowid Ho, PHARMD
F. Hoffmann-La Roche Ltd, Switzerland
Pharma Technical Regulatory Policy
Overcoming barriers to ATMPs: How the Revision of the EU Pharma Legislation will Boost ATMPs?
Lina Koufokotsiou
European Commission - DG SANTE, Belgium
Policy Officer
Current and Future Elements of the EU Framework from a Regulator’s Perspective
Caroline Pothet, PHARMD, RPH, RAC
European Medicines Agency, Netherlands
Head of advanced therapies and haemato-oncology