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The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.
The ICH Secretariat is pleased to announce the publication of ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management” Module 8 Training Material.
The ICH Secretariat is pleased to announce the publication of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” Training Material.
The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024.
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” has reached Step 2 of the ICH process on 5 February 2024.
ICH is launching a request for proposal for technical/regulatory writing services to support the drafting activities associated with ICH guideline development in support of ICH EWG Member and Observer representatives.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October & 1 November 2023, in Prague, Czech Republic in parallel of meetings of 16 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.