Back to Agenda
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)
Speaker: 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
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
Brazilian Experience with Master Protocols : Gustavo Mendes Lima Santos, MPharm
Herbal and Complementary Medicines Office - GMESP
Brazilian Health Regulatory Agency (ANVISA), Brazil
Have an account?