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Tuesday, June 29 • 4:00pm - 5:00pm
#264 SL: Multinational Collaborative CMC Review for Efficient and Rapid Product Approval

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Nagesh Bandi, PhD


A Collaborative Effort: CMC Experience with a Project Orbis Approval
Carol Krantz, PhD

ORBIS Experience: FDA Perspective
Anamitro Banerjee, PhD

Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
Stéphanie Parra, PhD

Compare and Contrast ACCESS and ORBIS: Health Canada Experiences Covering Small and Large Molecules
Fiona Cornel, MSc

avatar for Carol Krantz

Carol Krantz

Senior Director, Regulatory Affairs CMC, Seagen, United States
Carol Krantz is Sr. Director and Head of the Regulatory Affairs, CMC group at Seagen Inc. She received a B.A. in Biology from the University of Pennsylvania and a Ph.D. in Immunology/Microbiology from the University of Colorado before locating to Seattle to conduct post-doctoral studies... Read More →

Stéphanie Parra

Manager, New Drugs Quality Division, BPS, TPD, Health Canada, Health Canada, Canada
Stéphanie Parra is the manager for the New Drugs Quality Division (NDQD) in the Therapeutic Products Directorate (TPD) at Health Canada. Her division is responsible for the review of CMC information in NDS filed for small molecules. In that role, she was involved early on in Multinational... Read More →

Fiona Cornel

Acting Manager, Monoclonal Antibodies Division-Oncology, BRDD, Health Canada, Canada
Ms. Cornel is the Acting Manager of the Monoclonal Antibodies Division-Oncology (OMAD) of the Biologics and Radiopharmaceutical Drugs Directorate at Health Canada. She earned her MSc in Biology at Queen’s University in 1994 and joined the BRDD soon after as a research Biologist... Read More →
avatar for Christine Moore

Christine Moore

Executive Director, External Advocacy and Standards, Organon & Co., United States
Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... Read More →
avatar for Nagesh Bandi

Nagesh Bandi

Executive Director, Merck & Co., Inc, United States
Nagesh Bandi is currently an Executive Director of Pre-Approval regulatory CMC (New Products) at Merck & Co, wherein he is responsible for driving CMC regulatory strategy (early phase to post approval) and external advocacy-related. Nagesh is the past Chair of American Association... Read More →
avatar for Anamitro Banerjee

Anamitro Banerjee

Branch Chief, ONDP, OPQ, CDER, FDA, United States
Anamitro Banerjee is a Branch Chief in the Office of New Drug Products (ONDP), FDA. His branch supports all the 5 oncology clinical divisions in the OND and the Oncology Center of Excellence. The branch reviews all the INDs and NDAs for small molecules. The branch participates in... Read More →

Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session