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Session 7: Global Regulatory Landscape/Perspectives
Session Chair(s)
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
Speaker(s)
Gregory Levin, PhD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Speaker
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Speaker
Benjamin Hofner, PhD
Head of Data Science and Methods, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
A European Regulator’s View on Master Protocols
Gustavo Mendes Lima Santos, MPharm
Herbal and Complementary Medicines Office - GMESP, Brazilian Health Regulatory Agency (ANVISA), Brazil
Brazilian Experience with Master Protocols
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