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Risk management / Clinical research / Pharmaceuticals policy / Drug safety / Medical informatics / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Medical guideline / Food and Drug Administration / Medicine / Risk / Health


Final Concept Paper M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH M4E(R1) Guideline dated 10 February 2014 Endorsed by the ICH Steering Committee on 5 June 2014
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Document Date: 2014-10-10 07:42:02


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File Size: 155,35 KB

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

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FDA Phase / /

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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 / Q2 / /

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http /

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