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 Date: 2014-10-10 07:42:02Risk 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 |
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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