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Tuesday, June 21 • 9:15am - 10:15am
#215: Efforts Toward Global Convergence of CMC and GMP Expectations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-553-L04-P ; CME 1.00; RN 1.00

This session will discuss differences in CMC regulatory requirements globally and impact on access to medicines.

Learning Objectives

Describe differences in CMC regulatory requirements globally and impact on access to medicines; Identify opportunities and pathways to accelerate and align guidelines.

Chair

Judith Maxwell Silverman, PhD

Speaker

How to Accelerate the Supply of Medicines to all Populations Worldwide: A Regulatory Perspective - Much Needed Convergence of Post Approval Change Guidelines Worldwide
Diane Wilkinson, PhD, RPh

Accelerating Regulatory Approvals Through Global Collaborative Registration Procedures
Sharon Ayd, PhD, MBA

Regulatory Strategies to Achieve a Coalition's 100 Day Mission
Vincent Loh, PhD, RPh


Speakers
avatar for Max Silverman

Max Silverman

Program Officer, Vaccine Development and Surveillance, CMC, Bill & Melinda Gates Foundation, United States
avatar for Sharon Ayd

Sharon Ayd

Vice President and Principal, Regulatory COE, Advarra Consulting, United States
Sharon Ayd is a Life Sciences industry vertern with 35+ years of biopharma experience. She is currently VP & Principal, Regulatory Center of Excellence at Advarra Consulting. Sharon's experience has spanned from multi-national to spin-out & startup biotech companies. Her experience... Read More →
VL

Vincent Loh

Head of Global Regulatory Affairs CMC, Coalition For Epidemic Preparedness Innovations (CEPI) , United Kingdom
Vincent Loh obtained his B.Pharm and PhD in medicinal chemistry and molecular pharmacology at Nottingham University UK and is co-inventor of Lynparza, a first in class PARP inhibitor. He was a Senior Pharmaceutical Assessor at the MHRA for 10 years and was also the UK nominated expert... Read More →
avatar for Diane Wilkinson

Diane Wilkinson

Executive Director, Global CMC Regulatory Affairs, AstraZeneca, United Kingdom
Diane Wilkinson was awarded her B.Pharm at Nottingham and PhD in Pharmaceutical biotechnology at Manchester UK Universities. A 35 year career in the Pharmaceutical Industry. A strong advocate for regulatory harmonisation, as well as the use of science, risk based CMC approaches and... Read More →
avatar for Judith Silverman

Judith Silverman

Program Officer, Vaccine Development and Surveillance, CMC, Bill & Melinda Gates Foundation, United States

Tuesday June 21, 2022 9:15am - 10:15am CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Session