ICH: Assembly Meeting 2024 Recap

15.11.2024

News

Key highlights include:

ICH welcomed three new Observers: CPPS (Uzbekistan), DIGEMID (Peru), and Thai FDA (Thailand), bringing the total to 23 Members and 38 Observers.
Progress on guideline development:
- Draft ICH E6(R3) Annex 2 on Good Clinical Practice reached Step 2a/b.
- Draft ICH M15 on Model-Informed Drug Development reached Step 2a/b.
- ICH M13A on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 4.
- ICH E11A on Pediatric Extrapolation reached Step 4.
MedDRA (Medical Dictionary for Regulatory Activities) updates:
- Dr. Craig Simon from Health Canada elected as MedDRA Management Committee Vice-Chair.
- MedDRA Version 27.1 now available in 24 languages.
- Publication of MedDRA Points to Consider Companion Document Version 3.0 which features a new section on Manufacturing and Quality System Issues
Training Activities:
- Published ICH E8(R1) "General Considerations for Clinical Studies" Introductory Training Video
- Updated training materials for ICH Q8/Q9/Q10 Guidelines
ICH awarded the 2025 DIA Regional Inspire Award for Outstanding Contribution to Global Health.
The next ICH Assembly Meeting is scheduled for May 13-14, 2025, in Madrid, Spain.

Source:

ICH: News

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