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Regulatory Science Forum


Session 1: Setting the scene - Why is Regulatory Science research important?

Session Chair(s)

Sini  Eskola, MPharm, MS, MSc

Sini Eskola, MPharm, MS, MSc

  • Director Regulatory Affairs
  • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Regulatory Science is a field looking into developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medicines in order to assess their benefit-risk balance and facilitate a sound and transparent regulatory decision-making. It is the basis for the pharmaceutical regulation to evolve. It can be a fast-moving and exciting research area where for example advances in data analytics, ability to collect the real-world data and turn it into the real-world evidence to support regulatory decision making and rapidly advancing science are transforming the way new treatments are developed. To remain competitive, all regions have to continue to evolve their respective regulatory system to remain at the cutting edge of regulatory science and policy. It also requires collaboration between the regulators, academia, industry and patients. This session explores examples on what major regions and stakeholders are doing to advance their priority topics in regulatory science research and how that contributes to policy making and current practices/regulation.

Speaker(s)

Tony  Humphreys, MPharm

EMA Regulatory Science Strategy 2025

Tony Humphreys, MPharm

  • Head of the Regulatory Science and Innovation Task Force
  • European Medicines Agency, Netherlands
Tony  Humphreys, MPharm

Panel discussion with Q&A, with the participation of:

Tony Humphreys, MPharm

  • Head of the Regulatory Science and Innovation Task Force
  • European Medicines Agency, Netherlands
Gerald J. Dal Pan, MD, MHS

Panel discussion with Q&A, with the participation of:

Gerald J. Dal Pan, MD, MHS

  • Director, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Hubert  Leufkens, PharmD, PhD

Panel discussion with Q&A, with the participation of:

Hubert Leufkens, PharmD, PhD

  • Professor, Pharmaceutical Policy and Regulatory Science
  • Utrecht University, Netherlands
Susan  Longman

Panel discussion with Q&A, with the participation of:

Susan Longman

  • Head Regulatory Affairs Region Europe
  • Novartis Pharma AG, Switzerland

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