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Session 10: Next steps towards Maximizing the Value and Impact of Regulatory Science Research
Session Chair(s)
Hubert Leufkens, PharmD, PhD
Emeritus Professor of Pharmaceutical Policy and Regulatory Science
Utrecht University, Netherlands
Regulatory Science Research is an important driver for improvement of the Drug Regulatory System. Translation of the scientific findings to regulatory practice is a crucial step. This session will bring together the end-users of the system and those conducting regulatory science research. Discussions and debate will focus on value creation: How to identify areas in need of regulatory science research? How to best translate findings? How to maximize impact?
Speaker(s)
Panel discussion with Q&A
Tony Humphreys, MPharm
European Medicines Agency, Netherlands
Head of the Regulatory Science and Innovation Task Force
Panel discussion with Q&A
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Panel discussion with Q&A
Helga Gardarsdottir, PhD
Utrecht University, Netherlands
Associate Professor
Panel discussion with Q&A
Virginie Hivert, PharmD, PhD
Eurordis-Rare Diseases Europe, France
Therapeutic Development Director
Panel discussion with Q&A
Alan Morrison, PhD
MSD, United Kingdom
Vice President Regulatory Affairs Intl
Panel discussion with Q&A
Michael D. Nguyen, MD
FDA, United States
FDA Sentinel Program Lead, OSE, CDER
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