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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 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

• 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 webinar 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.
• pre-approved by 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.
• pre-approved by 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.
• approved by 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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