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Thursday, June 17 • 12:00pm - 1:00pm
#511 OD: Global Trends in Regulatory Reliance: Will the COVID-19 Experience Accelerate Implementation?

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Component Type: Session
Level: Intermediate

Explore growing trend of regulatory reliance, providing a global environmental scan of regulatory definitions and application of reliance policies. Feature perspectives on benefits and challenges to industry highlighting COVID-19 experiences.

Learning Objectives

Discuss the concepts of regulatory reliance and global trends in applying reliance; Explore the benefits and challenges to industry as a result of these trends; Identify from shared insights on reliance approaches related to licensing of COVID vaccines and therapeutics.

Chair

Jayne C. Ware, MPH, MS

Speaker

An Industry Perspective on Regulatory Reliance Trends
Rebecca Lumsden, PhD

Trends in Regulatory Reliance
Lawrence Liberti, PhD, RPh, RAC

Examples of Reliance Activities Implemented by Regulators and Their Perspectives Based on The International Pharmaceutical Regulators Programme (IPRP) Studies
Nobumasa Nakashima, PhD


Speakers
avatar for Jayne Ware

Jayne Ware

Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC , United States
Jayne Ware is a Director for Global Regulatory Policy at Merck. She joined Merck in 2012 after 15 years at the US FDA. Jayne is responsible for coordinating regulatory policy intelligence and advocacy activities for key topic areas at Merck such as digital health issues, safety/pharmacovigilance... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Director, D.K. Kim International Center for for Regulatory Science, University of Southern California Mann School of Pharmacy, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He... Read More →
avatar for Rebecca Lumsden

Rebecca Lumsden

Director, Regulatory Policy and Intelligence, Pfizer Inc, United Kingdom
Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017... Read More →

Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session