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Getting the Most Out of Scientific Advice in the US and EU
Session Chair(s)
Daniel Bollag, PhD
Chief Strategy Officer
Ocular Therapeutics, United States
This session will focus on how to obtain the best scientific advice from US and European health authorities. Presenters will discuss the optimal times in the drug development process to seek advice, timelines for obtaining advice, case examples and tips for procuring the most useful advice, and how to leverage that advice during subsequent development and agency interactions.
Learning Objective : Discuss regulatory approach to obtaining the best scientific advice from US and European health authorities during drug development.
Speaker(s)
Scientific Advice in the EU: How to Get the Best Out of It
Gopalan Narayanan, MD, FFPM, FRCP
Voisin Consulting Life Sciences, United Kingdom
Vice President, Disruptive Biologics
US/EU Scientific Advice Procedures: Improving Drug Development from the Authority’s Perspective
Leonardo Ebeling, DrMed, PhD
Dr. Ebeling & Assoc. GmbH, Germany
Managing Director
Scientific Advice: What You Get and What it Takes - A Regulator's View
Andrea Laslop, MD
Malta Medicines Authority, University of Innsbruck, Austria
Former Head of Scientific Office, AGES & Regulatory expert, lecturer