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Virtual | Virtual

Event Title
Joint US FDA – Health Canada ICH Public Meeting
February 22, 2024

February 22, 2024
11:00 AM - 3:00 PM ET


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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 4-5, 2024.

This public meeting will include presentations by FDA, Health Canada, PhRMA, and BIO experts on ICH guidelines recently reaching significant ICH milestones. Recently finalized ICH guidelines include analytical validation and analytical procedure development and viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Additional guidelines expected to be released for public consultation in coming months include post-approval safety data management: definitions and standards for expedited reporting and general principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines.


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.

This event is expected to be of broad interest to industry sponsors including innovator and generic companies.


  • ICH Background
  • ICH Guidelines Reaching or Approaching Key Milestones
    • Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development
    • Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
    • Q9(R1) Quality Risk Management
    • E6(R3) Good Clinical Practice Principles and Annex 1
    • M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines
    • E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
    • M12 Drug Interaction Studies
  • ICH Cell and Gene Therapy Reflection Paper
  • Q&A



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