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Terms of Reference, Membership and Report ISCB37 Birmingham 2016: AGM Wed 24 Aug

Terms of Reference, Membership and Report ISCB37 Birmingham 2016: AGM Wed 24 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 ISCB37 Birmingham 2016: AGM Wed 24 Aug

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  1. Terms of Reference, Membership and Report ISCB37 Birmingham 2016: AGM Wed 24 Aug ISCB Sub-Committee Statistics in Regulatory Affairs

  2. SiRA:Terms of Reference and Membership

  3. SiRA:Report • SiRA Sc commented on the FDA Draft Guidance on “Rare Diseases: Common Issues in Drug Development” in October 2015. • SiRA Sc held a Skype conference call in March 2016: • The main discussion topic was the Wikipedia Project on Statistics in Regulatory Affairs. • As decided during the conference call, a Poster is presented at the Birmingham ISCB conference in order to publicise the Wikipedia Project and involve the wider ISCB Membership. • The Wikipedia Project will also be publicised outside ISCB after the Birmingham ISCB Conference. • The Draft “Clinical Trial Protocol Template from the FDA and NIH”was circulated to ISCB in March 2016. • This was for information only, because the comments had to be submitted directly to the NIH.

  4. SiRA:Report • The EMA Draft “Guideline on evaluation of anticancer medicinal products in man” was circulated to the ISCB members in April 2016. The collection of comments from ISCB was terminated in July 2016. Comments were received from five members (Ralf Bender [IQWIG, DE]; Sorana Bolboacăr[IuliuHaţieganu Univ. of Medicine and Pharmacy Cluj-Napoca, RO]; Miland Joshi; Jonathan Siegel [Bayer, USA] and Ian White [MRC Biostatistics Unit, UK]) and the Swedish Pharmaceutical Society’s Section for Clinical Trials. The deadline for submission of consolidated comments to the EMA is 15 September 2016. • The ICH E17 Draft Guideline on “Multi-Regional Clinical Trials” was circulated to the ISCB members on12 August 2016 to collect comments by 15 December 2016.

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