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THE RISK-BASED APPROACH FOR NEW MEDICINES DEVELOPMENT: FROM ATMPS TO "CONVENTIONAL" DRUGS
Session Chair(s)
Beatriz Silva Lima, PHARMD, PHD
Director of FFUL, Faculty of Pharmacy
University of Lisbon, Portugal
The risk-based approach (RBA) for the safety assessment of ATMPs consists on product-based risk anticipation followed by confirmation, rather than risk observation followed by mechanistic understanding. Will predictive science allow using the RBA to study conventional drugs safety?
Learning Objective : -to understand the risk based approach to understand the program for medicines development to understand which are scientific aspects shared by small molecules, biologics and advanced therapies
Speaker(s)
Quality Aspects
Tobias Ostler, DRSC, MSC
Dr Regenold Gmbh, Germany
Senior Manager Scientific Affairs
Clinical Aspects
Andrea Laslop, MD
Malta Medicines Authority, University of Innsbruck, Austria
Former Head of Scientific Office, AGES & Regulatory expert, lecturer
Non-Clinical Aspects
Beatriz Silva Lima, PHARMD, PHD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy