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Wednesday, June 22 • 9:15am - 10:15am
#312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-605-L04-P ; CME 1.00; RN 1.00

Lessons learned from COVID-19 can transform the global regulatory system, but only with a thoughtful approach focused on measuring impact across stakeholders. The session discusses assessing impactful global regulatory agilities with this 360° lens.

Learning Objectives

Define impactful global regulatory agilities from the COVID-19 pandemic experience; Describe impacts to various stakeholders of these regulatory agilities; Appraise opportunities and challenges to embed best practices and lessons learned in regulatory agency practice globally to enhance routine action and prepare for the next pandemic.

Chair

Brenda Huneycutt, JD, PhD, MPH

Speaker

Industry Update
Kelly L. George, PhD, RAC

Patient Update
Annie Kennedy

Policy Perspective
Mark B. McClellan, MD, PhD

EMA Update
Marco Cavaleri, PhD

FDA Update
Peter W. Marks, MD, PhD


Speakers
avatar for Marco Cavaleri

Marco Cavaleri

Head of Health Threats and Vaccines Strategy, European Medicines Agency, Netherlands
Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present) Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009) Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008) Scientific Administrator, European... Read More →
avatar for Kelly George

Kelly George

Principal, Avalere Health, United States
Kelly L. George, PhD, RAC, supports clients in navigating the FDA policy environment for the development and lifecycle of drugs and biologics. Kelly applies her scientific and regulatory expertise toward the design and implementation of overarching drug development strategies to connect... Read More →
avatar for Annie Kennedy

Annie Kennedy

Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States
Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Mark McClellan

Mark McClellan

Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy, Duke-Margolis Center For Health Policy, United States
Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Margolis Center for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care including payment reform, real-world... Read More →

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session