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Wednesday, June 19 • 10:00am - 11:00am
#325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-643-L04-P; CME 1.00; RN 1.00

Global expert presentations and in-depth panel discussion on the regulatory agilities, regulatory reliance, platform approaches, and other regulatory innovations that are pivotal during public health emergencies and necessary for future pandemic preparedness.

Learning Objectives

Discuss regulatory agilities, reliance and platform approaches which significantly decreased review times internationally for COVID vaccines. Discuss additional CEPI case studies that highlight regulatory innovations to address future public health emergencies, and the inherent complexities of sustaining these innovations from a health authority perspective.

Chair

Helen Bayes Hartman, PhD

Speaker

Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
Donna Boyce, MS, RAC

Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
Debra A Yeskey

FDA Update
David C. Kaslow, MD

Moderator
Khushboo Sharma, MBA


Speakers
HH

Helen Hartman

Director, Global Regulatory Sciences, Pfizer Inc, United States
Helen has over 15 year of drug development experience as a global regulatory strategist and regulatory intelligence/policy professional across multiple therapeutic areas.
avatar for Donna Boyce

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for David Kaslow

David Kaslow

Director, Vaccines Research and Review (OVRR), CBER, FDA, United States
David is director of the Office of Vaccines Research and Review, CBER, US FDA, where he oversees regulation of vaccines, allergenics, live biotherapeutics and bacteriophage. His 35+ years of experience in use-inspired research, product development, and product introduction include... Read More →
avatar for Khushboo Sharma

Khushboo Sharma

Chief Regulatory Innovation Officer, Accumulus Synergy, United States
Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles... Read More →
DY

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum