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Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle
Session Chair(s)
Shannon Thor, PHARMD, MS
Deputy Director, Office of Global Policy & Strategy, Europe Office
FDA, United States
The Parallel Scientific Advice (PSA) procedure is a process for EMA and FDA to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and biologics). Such interactions are expected to increase dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, provide a deeper understanding of the bases of regulatory decisions, optimize product development, and avoid unnecessary testing replication or unnecessary diverse testing methodologies. This session will be led by EMA and FDA PSA participants and program managers, as well as a participant offering the industry perspective. Attendees will better understand the PSA procedure, how to apply, and expectations on outcomes.
Learning Objective : Explain the Parallel Scientific Advice (PSA) procedure framework and timelines; Identify best candidates for PSA and best practices for request letters; review statistics on utilization of the PSA procedure; Describe Industry’s and each Agency’s unique perspective and contribution to PSA.
Speaker(s)
PSA: FDA Division Perspective
Kelly Richards, MSN, RN, RAC
FDA, United States
Senior Regulatory Health Project Manager, Gastroenterology , ORO, OND, CDER
PSA: EMA Perspective
Thorsten Vetter, DrMed
European Medicines Agency, Netherlands
Senior Scientific Officer, Scientific Advice
PSA: A Sponsor Perspective
Petra Pavlickova, PHD, RAC
Bristol-Myers Squibb Company, United States
Associate Director, Regulatory Affairs