Virtual
Event Title
Joint US FDA – Health Canada ICH Public Meeting
February 24, 2023
- Date:
- February 24, 2023
- Time:
- 1:00 PM - 4:30 PM ET
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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.