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Master Protocol Workshop

Session 7: Global Regulatory Landscape/Perspectives

Session Chair(s)

Daniel Millar, MBA

Daniel Millar, MBA

  • Senior Director, Strategic Business Transformation
  • Janssen Research & Development, 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

Speaker(s)

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 Section Biostatistics
  • Paul-Ehrlich-Institut, 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