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16th November 2022
The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials reached Step 4 of the ICH Process in September 2022.
Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Expert Working Group.
Please find on the Efficacy Guidelines page the Step 4 Introductory Training Presentation for download.