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In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies.
The Q3D Training Modules 8-9 (Module 8: Case Studies; Modules 9: FAQ document) can now be found on the ICH website.
The revised version of the ICH M4(R3) Guideline on the overall organisation of the CTD including the Granularity Document reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).
The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization (MSSO).
The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization (MSSO).
The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).
The Questions and Answers Document of the ICH S9 Guideline on Non Clinical Evaluation for Anticancer Pharmaceuticals reached Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3).
The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3).