Understanding ICH Q12 Regulatory and Technical Considerations to Manage Post Approval Changes

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January 17, 2023 from 8:00am to 1:00pm EST

Virtual

Registration is open now until January 11, 2023.

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The CAPRA Symposium Committee will host a half-day virtual interactive session to provide an update on the implementation of ICH Q12 in Canada and the changes made to the Post-NOC changes guidance document to support the implementation.

Attendees will learn the objectives and the scope of the ICH Q12 guidelines and the impact and benefits of its implementation. This symposium will also share recent pilot program experiences on Established Conditions (ECs) and Post Approval Change Management Protocols (PACMPs) from both Health Canada and Industry.

This symposium will provide attendees with an opportunity to raise questions and concerns about this topic.

This event will be of interest to:
·        Regulatory Affairs professionals for pharmaceuticals and biologics;
·        Pharmaceutical Scientists and Quality Assurance personnel;
·        Research and Development Scientists;
·        Manufacturing & Technical Services Subject Matter Experts.

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Speakers / Panelists

Dr. Anthony Ridgway
Dr. Anthony Ridgway

Dr. Ridgway retired from Health Canada (HC) in May 2020, was subsequently awarded Scientist Emeritus status, and has been working to help HC implement ICH-Q12. After completing his Ph.D. at McGill University in Montréal, he moved to post-doctoral studies and 5 years as Assistant Professor at the University of Western Ontario pursuing research on oncogenes, retroviral & lentiviral regulatory genes, and inducible expression vectors. He joined HC’s Bureau of Biologics in 1991 and, in 1999, became Manager of the Biotherapeutics Division with responsibility for regulation of a wide range of biologics and radiopharmaceuticals. In 2004, during creation of the Biologics and Genetic Therapies Directorate (renamed Biologic and Radiopharmaceutical Drugs Directorate in 2020) he transformed his division into three new divisions and became The Senior Regulatory Scientist, Office of the Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB). This role included advisory responsibilities and retention of managerial responsibility for the evaluation of product quality for radiopharmaceuticals, gene therapy products and many cell therapy products. For 18 months, extending from 2016 into 2018, he served as Acting Director of CERB.

He has been extensively involved in international harmonisation activities, interacting with other regulatory agencies, the WHO, and other non-commercial and commercial entities. He first represented HC at the ICH in 1993 and repeated such activity frequently, serving on EWGs addressing the quality of biotechnology products. He was the HC Topic Lead for three ICH Considerations and eight ICH Guidelines, the last being ICH-Q12 on product lifecycle management. From 2000 to 2020, he served four, 5-year terms on USP Committees of Experts; two for “Cell, Gene and Tissue Therapies” followed by two for “General Chapters – Biological Analysis”. During his 29-year career with Health Canada he was a frequently requested panelist and speaker at scientific conferences, and other events, addressing many aspects of the manufacturing and regulation of biotherapeutics.
Hugo Hamel, Associate Director

Center for Blood, Blood Products and Biotherapeutics (CBBB) Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Hugo Hamel, Associate Director

Center for Blood, Blood Products and Biotherapeutics (CBBB) Biologic and Radiopharmaceutical Drugs Directorate (BRDD)

Hugo Hamel graduated from the University of Montreal with a B.Sc. in Biochemistry, a M.Sc. in Molecular Biology and a M.Sc. in Pharmaceutical Sciences. He also graduated with a MBA in 2015.

Mr. Hamel spent his last 22 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator with the Monoclonal Antibodies Division and Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division. He is currently Associate Director with the Center for Blood, Blood Products and Biotherapeutics at BRDD.

During his career with BRDD, Mr. Hamel was involved with reviewing the Chemistry, Manufacturing and Controls information pertaining to Clinical Trial Applications (CTAs), New Drug Submissions (NDSs) and Post-Marketing changes associated with Biotherapeutics. He also acted from 2005-2022 as the BRDD lead of the working group in charge of developing and updating the Canadian Post-NOC changes quality guidance and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products.

Mr. Hamel is also a member of the ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his perspective on the implementation of this important guideline in Canada.
Connie Langer

Global Regulatory CMC Director at Pfizer
Connie Langer

Global Regulatory CMC Director at Pfizer

Connie Langer is a chemical engineer and director at Pfizer Global Regulatory Affairs, CMC in Groton, CT with over 24 years’ experience in the pharmaceutical industry. She is currently accountable to recommend strategic regulatory options to achieve product approvals globally. She is a member of both ISPE PQLI® ICH Q12 and RQHC Modernization of Module 3 Working Teams, a member of PhRMA ICH M4Q Limited Duration Team, and chair of the IQ ICH Q12 Working Group. Connie holds a BS and MS from the University of Connecticut, and a Drug Development Certificate from Temple University.
Jennifer Wilhelm

Director, Regulatory Affairs at Merck Canada
Jennifer Wilhelm

Director, Regulatory Affairs at Merck Canada

Jennifer (JJ) Wilhelm is a regulatory affairs professional working in the biopharmaceutical industry, as Director, Regulatory Affairs at Merck Canada Inc (Merck). She started in industry at a toxicology consulting firm working for companies mainly at initial/FIH clinical trial stage, then worked for Canadian biotech companies at the clinical trial stage and has been with Merck since 2011. JJ holds an Honours BSc in Biomedical Sciences from the University of Guelph, an MSc in Pharmacology and Toxicology from McGill University, and an eMBA from JMSB at Concordia University, as well as the RAC (US) credential from RAPS.

JJ is currently focused on CMC aspects of regulatory applications in Canada, pre-approval to post-market, as well as related areas such as Drug Establishment Licensing (DEL), Drug Shortages, New Substances Notifications for Organisms [NSN(O)], and Medical Device requirements. She is actively involved in several Health Canada policy activities, with the Innovative Medicines Canada (Quality group), BIOTECanada (Biologics Regulatory Affairs Group), and recently with Merck as part of the ICH Q12 pilot.