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Virtual Event

Oct 08, 2020 10:15 AM - Oct 09, 2020 2:00 PM

Horsham, PA 19044

Master Protocol Workshop

Session 7: Global Regulatory Landscape/Perspectives

Session Chair(s)

Daniel  Millar, MBA

Daniel Millar, MBA

Senior Director, Strategic Business Transformation

Johnson & Johnson, United States

The unprecedented COVID-19 experience accelerated the call for Master Protocols from global regulators, as a means of generating timely and substantial evidence to help patients and to utilize research sites efficiently. This session will focus on how regulatory views are evolving and will address important challenges.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify similarities and differences in regulator experience, procedures, and opportunities for consultant
  • Evaluate how the regulatory environment for Master Protocols has changed since the COVID-19 experience
  • Identify specific points of attention to be successful with Master Protocol approaches to meet regulatory requirements


Gregory  Levin, PhD

Speaker: Gregory Levin, PhD

Associate Director for Statistical Science and Policy, OB, OTS, CDER

FDA, United States

Dionne  Price, PhD

Speaker: Dionne Price, PhD

Deputy Director, Office of Biostatistics, OTS, CDER

FDA, United States

Benjamin  Hofner, PhD

A European Regulator’s View on Master Protocols: Benjamin Hofner, PhD

Head of Data Science and Methods

Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany

Gustavo  Mendes Lima Santos, MPharm

Brazilian Experience with Master Protocols : Gustavo Mendes Lima Santos, MPharm

Herbal and Complementary Medicines Office - GMESP

Brazilian Health Regulatory Agency (ANVISA), Brazil

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