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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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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