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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

Expert presentations and panel discussion on the regulatory agilities which decreased review times for SARS-COV-2 vaccines and incorporation of these agilities in the new US Platform Tech Designation and EFPIA-proposed Dynamic Regulatory Assessment.

Learning Objectives

Discuss regulatory agilities and reliance approaches which significantly decrease review times internationally; Discuss the potential impact of recent US legislative initiatives including Platform Technology Designation and the EFPIA-proposed Dynamic Regulatory Assessment on drug development timelines as well as the opportunities and risks of these new initiatives.

Chair

Helen Bayes Hartman, PhD

Speaker

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

Panelist
Khushboo Sharma, MBA

Panelist
David C. Kaslow, MD


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 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