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About This Webinar
Join the regional public meeting co-hosted by FDA and Health Canada in preparation for the upcoming ICH Biannual Assembly meeting. This session will feature presentations from experts in the field, including FDA, Health Canada, PhRMA, and BIO. Key highlights include recently finalized ICH guidelines and insights into upcoming releases for public consultation.
Intended Audience
North American regulators, industry professionals, and stakeholders interested in ICH efforts to establish global standards for pharmaceuticals. The event will be valuable for industry sponsors, both innovator and generic companies.
Topics Covered
- ICH Background
- Milestones in ICH Guidelines
- Analytical Validation and Procedure Development
- Viral Safety Evaluation of Biotechnology Products
- Quality Risk Management
- Good Clinical Practice Principles
- Pharmacoepidemiological Studies with Real-World Data
- Post-Approval Safety Data Management
- Drug Interaction Studies
- ICH Cell and Gene Therapy Reflection Paper
- Q&A Session
Don’t miss this opportunity to stay informed and contribute to the development of scientifically-driven global standards. Visit the official webinar to register and for additional information including CE credit availability.
Please note that an external entity hosts this event.
