ICH Project ICH Q9 (R1) Guideline Briefing Session
Oct 12, 2023
The ICH Q9(R1) Expert Working Group (EWG) has been studying to develop guidelines for quality risk management.
As a result, the draft ICH Q9(R1) Guideline reached Step 4 as of January 18, 2023, and was published on the official ICH website and issued as a notice by the Ministry of Health, Labour and Welfare in Japan on August 31, 2023. We held a briefing session on the ICH Q9(R1) Guideline in the hope that the purpose and contents of this guideline will be widely known to those involved in the pharmaceutical industry and that the guideline will be appropriately utilized.
The program and other details of the briefing can be found on the PMDA Website.
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