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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)
A Collaborative Effort: CMC Experience with a Project Orbis Approval
Carol Krantz, PhD
Seagen, United States
Senior Director, Regulatory Affairs CMC
ORBIS Experience: FDA Perspective
Anamitro Banerjee, PhD
FDA, United States
Branch Chief, ONDP, OPQ, CDER
Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
Stéphanie Parra, PhD
Health Canada, Canada
Manager, New Drugs Quality Division, BPS, TPD, Health Canada
Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
Fiona Cornel, MSc
Health Canada, Canada
Acting Manager, Monoclonal Antibodies Division-Oncology, BRDD
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