M14 Use of real-world data in pharmacoepidemiological studies

M14 EWG General principles on planning and designing pharmacoepidemiological studies that utilize real-world data for safety assessment of a medicine

This topic was endorsed by the ICH Assembly in June 2021, and an informal Working Group has been established to develop a Concept Paper and Business Plan.

Endorsed Documents (Click the links below for complete guidelines)




M14 Use of real-world data in pharmacoepidemiological studies:

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