COVID-19: Implications for the Future of Regulatory

Friday, October 30, 2020

16:00 – 17:00 CET

Session Leader(s)

Pallavi Trivedi, MPH, RAC

Head of Global Regulatory Affairs and Compliance
Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Leicester, England, United Kingdom

Panelist(s)

Fergus Sweeney
Stephanie O. Omokaro, MD

Division Deputy Director
U.S. Food & Drug Administration
SA

Sharry Arora

The COVID-19 pandemic has caused regulators and industry to collaborate in new ways and at rapid speed. This panel will provide an overview of how broad stakeholders have worked together to overcome a unique set of challenges. Different regulators have approached similar challenges in different ways. This session will further explore which regulatory pathways have been streamlined while continuing to demonstrate safety and efficacy. The session will be forward looking reflecting on the questions: if a pandemic arose next year, what would we do differently? And can we ever truly be prepared for a pandemic? The panelists will further reflect on how the events of the past year will alter the shape and structure of the regulatory department of the future.

Learning Objectives:

Review collaboration between industry working in conjunction with regulators
Explore how have regulatory pathways been streamlined while still demonstrating safety and efficacy.
Compare and contrast lessons learned from the development of new processes and pathways during the past year
Discuss different ways that the regulatory department may be different as a result of the events of the past year.