Prior to the next ICH Biannual Assembly meeting the FDA and Health Canada are hosting a virtual public meeting on 22February 2024 from 11:00 AM to 3 PM ET.
A large number of ICH guidelines that are reaching milestones are listed at the announcement website to be presented and discussed:
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
The full agenda and registration are available at the website(https://www.fda.gov/drugs/news-events-human-drugs/joint-us-fda-health-canada-ich-public-meeting-02222024?utm_medium=email&utm_source=govdelivery)
#FDA #HealthCanada #ICHdraftguidelines
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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