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Pharmaceuticals policy / Management / Safety / Actuarial science / Ethics / Environmental Working Group / Risk / Clinical research / Drug safety / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use


Final Concept Paper M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH M4E(R1) Guideline Revised on 23 March 2015 Endorsed by the ICH Steering Committee on 27 March 2015
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Document Date: 2015-04-14 09:36:09


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File Size: 185,96 KB

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Expert Working Group / Harmonisation Action Proposed An ICH Expert Working Group / /

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web conferences / /

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ICH Steering Committee / FDA / Steering Committee / World Health Organization / Human Use ICH Secretariat / European Union / /

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R1 / R2 / /

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