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Virtual | Virtual

Event Title
Joint US FDA – Health Canada ICH Public Meeting
February 24, 2023


Date:
February 24, 2023
Time:
1:00 p.m. - 4:30 p.m. ET

Topic & Presentations

Speakers

Joint US FDA – Health Canada ICH Public Meeting

 

 

Opening Remarks

Theresa M Mullin, Ph.D.
Associate Center Director - Strategic Initiatives
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)

Overview of ICH

Nick Orphanos
Senior Policy Analyst
Pharmaceutical Drugs Directorate
Health Canada

Bioanalytical Method Validation and Study Sample Analysis

Anna Edmison, Ph.D.
Senior Clinical Assessment Officer
Division of Biopharmaceutics Evaluation
Pharmaceutical Drugs Directorate
Health Canada

Clinical Electronic Structured Harmonized Protocol

Vivian Combs, M.S.
Senior Director and Process Owner
Clinical Foundations
Lilly Research Laboratories
Eli Lilly and Company

Drug Interaction Studies

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)

Bioequivalence for Immediate-Release Solid Oral Dosage Forms

John Gordon, Ph.D.
Senior Clinical Assessment Officer
Division of Biopharmaceutics Evaluation
Bureau of Pharmaceutical Sciences
Pharmaceutical Drugs Directorate
Health Canada

A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials

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)

Rodent Carcinogenicity Studies for Human Pharmaceuticals and Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Alisa Vespa, Ph.D.
Senior Scientific Evaluator
Therapeutic Products Directorate
Health Canada

Biodistribution Studies for Gene Therapy Products

Sharon Choi, Ph.D.
Senior Scientific Evaluator
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Health Canada

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

 

Chris Storbeck, Ph.D.
Senior Quality Evaluator
Gene Therapies Division
Center for Biologics Evaluation
Health Canada

Continuous Manufacturing

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)

Q&A Discussion Panel

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

 

Agenda

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ABOUT THIS WEBINAR

FDA and Health Canada will be co-hosting a regional public meeting to provide information to stakeholders and solicit input prior to the next ICH biannual Assembly meeting scheduled for June 12-13, 2023.

The public meeting will include presentations by FDA, Health Canada, and PhRMA experts on ICH guidelines recently reaching significant ICH milestones. For example, guidelines recently released for public consultation include a harmonized clinical trial protocol and viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Recently finalized ICH guidelines include continuous manufacturing and bioanalytical method validation.

TOPICS COVERED

  • ICH Background
  • ICH Guidelines Reaching Key Milestones
    • Clinical Electronic Structured Harmonized Protocol
    • Drug Interaction Studies
    • Bioequivalence for Immediate-Release Solid Oral Dosage Forms
    • A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
    • Rodent Carcinogenicity Studies for Human Pharmaceuticals
    • Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
    • Biodistribution Studies for Gene Therapy Products
    • Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
    • Continuous Manufacturing
    • Bioanalytical Method Validation

INTENDED AUDIENCE

North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and harmonize scientifically driven, global standards for safe, effective, and high-quality pharmaceuticals.

FDA RESOURCES

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