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De-risking Regulatory Strategy for ATMPs
Session Chair(s)
Paula Salmikangas, PHD
Advisory Board, Director of Biopharmaceuticals and ATMPs
NDA Group, United Kingdom
This session is planned to address the main regulatory challenges currently hampering development of ATMPs and to describe how to mitigate the risks of regulatory failures, both from regulatory and industrial perspectives.
Learning Objective : Provide info on current challenges in ATMP development & commercialization both from regulatory & industrial perspective Address the pre-clinical safety studies before FIM studies, which often pose significant challenges for ATMP developers Guide how to build de-risking strategies for successful development paths Describe the value of a target product profile & a risk-based approach for ATMPs
Speaker(s)
Key Regulatory Challenges of ATMP Development
Paula Salmikangas, PHD
NDA Group, United Kingdom
Advisory Board, Director of Biopharmaceuticals and ATMPs
Pre-clinical Safety Studies for ATMPs before First in Human Study
Beatriz Silva Lima, PHARMD, PHD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy
Building a Successful Regulatory Strategy for Ex-Vivo Gene Therapies Targeting Rare Diseases
Anne Dupraz-Poiseau
Orchard Therapeutics, France
Chief Regulatory Officer