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Virtual Event

Sep 28, 2020 2:00 PM - Sep 30, 2020 6:00 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

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

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)

Tony  Humphreys, MPharm

Panel discussion with Q&A

Tony Humphreys, MPharm

European Medicines Agency, Netherlands

Head of the Regulatory Science and Innovation Task Force

Peter  Mol, PharmD, PhD

Panel discussion with Q&A

Peter Mol, PharmD, PhD

MEB, Netherlands

CHMP member, NL

Helga  Gardarsdottir, PhD

Panel discussion with Q&A

Helga Gardarsdottir, PhD

Utrecht University, Netherlands

Associate Professor

Virginie  Hivert, PharmD, PhD

Panel discussion with Q&A

Virginie Hivert, PharmD, PhD

Eurordis-Rare Diseases Europe, France

Therapeutic Development Director

Alan  Morrison, PhD

Panel discussion with Q&A

Alan Morrison, PhD

MSD, United Kingdom

Vice President Regulatory Affairs Intl

Michael D. Nguyen, MD

Panel discussion with Q&A

Michael D. Nguyen, MD

FDA, United States

FDA Sentinel Program Lead, OSE, CDER

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