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Regulatory Science Forum
Session 10: Next steps towards Maximizing the Value and Impact of Regulatory Science Research
Session Chair(s)
Hubert Leufkens, PharmD, PhD
- Professor, 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
- Principal Clinical Assessor, University Medical Center Groningen; Member SAWP /
- CBG-MEB (dutch Medicines Evaluation Board) / University Medical Center Groningen, Netherlands
Panel discussion with Q&A
Helga Gardarsdottir, PhD
- Associate Professor
- 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