Joint US FDA - Health Canada ICH Public Meeting

FDA and Health Canada co-hosted a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly meeting, which included presentations by FDA, Health Canada, and PhRMA experts on ICH guidelines recently reaching significant ICH milestones.
Timestamps
01:00 - Opening Remarks
05:00 - Overview of ICH
17:42 - Bioanalytical Method Validation and Study Sample Analysis
33:42 - Clinical Electronic Structured Harmonized Protocol
49:08 - Drug Interaction Studies
01:02:20 - Bioequivalence for Immediate-Release Solid Oral Dosage Forms
01:19:58 - A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
01:46:55 - Rodent Carcinogenicity Studies for Human Pharmaceuticals and Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
02:10:42 - Biodistribution Studies for Gene Therapy Products
02:24:22 - Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
02:39:38 - Continuous Manufacturing
02:52:32 - Q&A Discussion Panel
Speakers:
Theresa M Mullin, Ph.D.
Associate Center Director - Strategic Initiatives
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Nick Orphanos
Senior Policy Analyst
Pharmaceutical Drugs Directorate
Health Canada
Anna Edmison, Ph.D.
Senior Clinical Assessment Officer
Division of Biopharmaceutics Evaluation
Pharmaceutical Drugs Directorate
Health Canada
Vivian Combs, M.S.
Senior Director and Process Owner
Clinical Foundations
Lilly Research Laboratories
Eli Lilly and Company
Raj Madabushi, Ph.D.
Associate Director
Guidance and Scientific Policy
Office of Clinical Pharmacology
Officer of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
John Gordon, Ph.D.
Senior Clinical Assessment Officer
Division of Biopharmaceutics Evaluation
Bureau of Pharmaceutical Sciences
Pharmaceutical Drugs Directorate
Health Canada
Mary T. Thanh Hai, M.D.
Deputy Director for Clinical Office of New Drugs
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Alisa Vespa, Ph.D.
Senior Scientific Evaluator
Therapeutic Products Directorate
Health Canada
Sharon Choi, Ph.D.
Senior Scientific Evaluator
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Health Canada
Chris Storbeck, Ph.D.
Senior Quality Evaluator
Gene Therapies Division
Center for Biologics Evaluation
Health Canada
Sau (Larry) Lee, Ph.D.
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Panelists:
Panelists include above speakers and:
Ron Fitzmartin, PhD, MBA
Sr. Informatics Advisor
Office of Regulatory Operations (ORO)
Center for Biologics Evaluation and Research (CBER)
Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER
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