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Terms of Reference, Membership and Report ISCB35 Vienna 2014: AGM Wed 27 Aug

Terms of Reference, Membership and Report ISCB35 Vienna 2014: AGM Wed 27 Aug. ISCB Sub-Committee Statistics in Regulatory Affairs. SiRA : Terms of Reference and Membership. SiRA : Report.

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Terms of Reference, Membership and Report ISCB35 Vienna 2014: AGM Wed 27 Aug

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  1. Terms of Reference, Membership and Report ISCB35 Vienna 2014: AGM Wed 27 Aug ISCB Sub-Committee Statistics in Regulatory Affairs

  2. SiRA: Terms of Reference and Membership

  3. SiRA:Report • SiRA commented on the EMA guideline: “Guideline on the investigation of subgroups in confirmatory clinical trials” (EMA/CHMP/539146/2014). • SiRA has not submitted any comments on the EMA draft of “Qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty” (EMA/CHMP/SAWP/592378/2013) as we were happy with EMA’s proposal.

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