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Topics & Presentations	Speakers
Joint US FDA – Health Canada ICH Public Meeting – Part 1
Opening Remarks	Dr. Leo Bouthillier Director, Centre for Blood, Blood Products and Biotherapeutics Biologic and Genetic Therapies Directorate Health Products and Food Branch Health Canada (HC)
Overview of ICH	Jill Adleberg ICH Coordinator Center for drug Evaluation and Research (CDER) | FDA
Updates on ICH Efficacy Related Guidelines: M12, Drug Interaction Studies	Kellie Reynolds, Pharm.D. Director Division of Infectious Disease Pharmacology (DIDP) Office of Clinical Pharmacology (OCP) CDER | FDA
E2D(R1), Post-Approval Safety Data Management: Definitions and Standards for Management and Reporting of Individual Case Safety Reports	Craig Zinderman, MD, MPH Associate Director for Medical Policy Office of Biostatistics and Pharmacovigilance (OBPV) Center for Biologics and Research (CBER) | FDA
E6(R3) Good Clinical Practice Principles and Annex 1	Carole Légaré, MD Senior Advisor, Office of Clinical Trials Pharmaceutical Directorate Health Products and Food Branch | HC
M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines	Melissa Kampman, PhD Manager, Data Analytics and Real world Evidence Division Marketed Health Products Directorate | HC
Joint US FDA – Health Canada ICH Public Meeting – Part 2
Q2(R2)/Q14, Revision of Q2(R1) Analytical Validation and Analytical Procedure Development	David Keire, PhD Director Office of Testing Research (OTR) Office of Pharmaceutical Quality (OPQ) CDER | FDA
Q5A(R2), Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin	Chris Storbeck, PhD Senior Quality Evaluator Cell, Gene Therapies, and Radiopharmaceuticals Division Center for Oncology Radiopharmaceuticals and Research Evaluation | HC
Q9(R1), Quality Risk Management	Stephen Mahoney, MS, JD Head of Quality Policy & Advocacy Gilead
Cell and Gene Therapies Discussion Group	Kathleen Francissen, PhD. Global Head PT Cell & Gene Therapy Regulatory Genentech, A Member of the Roche Group
Q&A Discussion Panel	Jill Adleberg, Chris Storbeck, Kellie Reynolds, Craig Zinderman, Melissa Kampman, David Keire, Kathleen Francissen, Stephen Mahoney, and Nick Orphanos Senior Policy & ICH Coordinator Health Products and Food Branch | HC M. Khair ElZarrad, PhD, MPH Director Office of Medical Policy (OMP) CDER | FDA

 

 

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 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.

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.

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

TOPICS COVERED

• 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

FDA RESOURCES

• ICH website
• FDA ICH page
• Health Canada ICH page