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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

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)

Tony  Humphreys, MPharm

Panel discussion with Q&A

Tony Humphreys, MPharm

  • Head of the Regulatory Science and Innovation Task Force
  • European Medicines Agency, Netherlands
Peter  Mol, PharmD, PhD

Panel discussion with Q&A

Peter Mol, PharmD, PhD

  • Principal Clinical Assessor, University Medical Center Groningen; Member SAWP
  • CBG-MEB (Dutch Medicines Evaluation Board), Netherlands
Helga  Gardarsdottir, PhD

Panel discussion with Q&A

Helga Gardarsdottir, PhD

  • Associate Professor
  • Utrecht University, Netherlands
Virginie  Hivert, PharmD, PhD

Panel discussion with Q&A

Virginie Hivert, PharmD, PhD

  • Therapeutic Development Director
  • Eurordis-Rare Disease Europe, France
Alan  Morrison, PhD

Panel discussion with Q&A

Alan Morrison, PhD

  • Vice President Regulatory Affairs Intl
  • Merck Sharp & Dohme, United Kingdom
Michael D. Nguyen, MD

Panel discussion with Q&A

Michael D. Nguyen, MD

  • FDA Sentinel Program Lead, OSE, CDER
  • FDA, United States

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