1. Terms of Reference, Membership and Report ISCB36 Utrecht 2015: AGM Wed 26 Aug ISCB Sub-Committee Statistics in Regulatory Affairs

2. 2 InformationTerms of Reference Members Statistics in Regulatory Affairs iscb‑reg-aff@ googlegroups.com The subcommittee on Regulatory Affairs will review, comment upon and seek to influence the development of regulatory requirements, guidelines and other documents concerning the scientific aspects of data generation, collection, management, analysis, and reporting. In general, the subcommittee will seek out and handle all regulatory issues in the name of the Society with the approval of the President or in his/her absence, the Vice ‑ President. Chair: Harbajan Chadha-Boreham (CH)* Secretary: Nicole Close (USA)* Members: Ralf Bender (DE) Tim Friede (DE) Christoph Gerlinger (DE) Thomas Jaki (UK ) + Stanislav Katina (CZ) + Christos Nakas (GR) Martin Schumacher (DE) Jørgen Seldrup (FR) Juan Torres (ES, CH) + Chris Weir (UK) + * Position changed; + New members Resigned: Jen-Pei Liu (TW) Resigned : Lutz Edler (DE)

3.  SiRA is piloting a new process for reviewing and commenting on draft regulatory guidelines:  Expert Review Committee (ERC) of ISCB members (including SiRA, as appropriate), who use Google-Docs as an aid to reaching consensus.  ISCB members’ comments are elicited for consolidation by the ERC.  FDA Draft Guidance “Adaptive Designs for Medical Device Clinical Studies” was circulated by SiRA for review/comment to be conducted via the above-mentioned process.  SiRA circulated an ICH-E9 survey to ISCB members, which relates to an addendum on issues surrounding “estimands, missing data and sensitivity analyses in the design and analysis of clinical trials”.  SiRA investigated the feasibility of the academic community being involved through ISCB during drafting of the “Addendum for ICH E6: Guideline for Good Clinical Practice”. The idea was abandoned.  The ICH Expert Working Groups are restricted to delegates from regulatory authorities and industry.  SiRA will wait for the release of the draft ICH-E6 Addendum for comment. 3