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Multinational Collaborative CMC Review for Efficient and Rapid Product Approval
Session Chair(s)
Nagesh Bandi, PhD
Executive Director, Merck & Co., Inc, United States
International collaboration for regulatory review of new drugs is a burgeoning area with little experience, especially related to the CMC (chemistry, manufacturing and controls) information. Recognition and reliance approaches to regulatory review could improve the efficiency of the review process for both industry and regulators, and lead to more aligned regulatory outcomes that could simplify post approval change logistics. This session will explore regulatory agency collaborations for the CMC related aspects of regulatory submissions. Both industry and regulator experience will be shared for programs such as Access (involving Australia, Canada, Switzerland, Singapore, and UK) and Project Orbis (led by US FDA for oncology drugs and involving the ACCESS markets and Brazil).
Learning Objective : Identify major programs and regulatory agencies involved in collaborative regulatory reviews; Describe the advantages and challenges associated with multi-national collaborative review of CMC (chemistry, manufacturing and controls) regulatory information; Discuss how ACCESS and Project Orbis align in approach and outcome, but also how they differ.
Speaker(s)
Carol Krantz, PhD
Senior Director, Regulatory Affairs CMC, Seagen, United States
A Collaborative Effort: CMC Experience with a Project Orbis Approval
Anamitro Banerjee, PhD
Branch Chief, ONDP, OPQ, CDER, FDA, United States
ORBIS Experience: FDA Perspective
Stéphanie Parra, PhD
Manager, New Drugs Quality Division, BPS, TPD, Health Canada, Health Canada, Canada
Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
Fiona Cornel, MSc
Acting Manager, Monoclonal Antibodies Division-Oncology, BRDD, Health Canada, Canada
Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
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