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Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
9th - 10th September, Cambridge, UK
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EMA - Overview of comments received on ICH M11 Technical Specification Updated Step 2b
12th June 2025
EMA - Overview of comments received on ICH M11 Technical Specification Updated Step 2b
The ICH M11 draft guidelines covers the clinical study protocol template and technical specifications. Following the end of public consultation on 22 April 2025 on the revised draft ICH M11 Technical Specification, an overview of received comments has now been published on the EMA website.
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