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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
Head of the Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Panel discussion with Q&A
Peter Mol, PharmD, PhD
CHMP member, NL, MEB, Netherlands
Panel discussion with Q&A
Helga Gardarsdottir, FISPE
Professor RWD for decision making on medicines, Utrecht University, Netherlands
Panel discussion with Q&A
Virginie Hivert, PharmD, PhD
Therapeutic Development Director, Eurordis-Rare Diseases Europe, France
Panel discussion with Q&A
Alan Morrison, PhD
Vice President Regulatory Affairs Intl, MSD, United Kingdom
Panel discussion with Q&A
Michael D. Nguyen, MD
FDA Sentinel Program Lead, OSE, CDER, FDA, United States
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