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Virtual | Virtual

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


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

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

Visit CDER Small Business and Industry Assistance Page

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

 

 
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