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

2. SiRA: Terms of Reference and Membership
Information
Terms of Reference
Members
Statistics in Regulatory Affairs 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 (FR)
Secretary:
Nicole Close (USA)
Members:
1. Ralf Bender (DE)
2. Tim Friede (DE)
3. Christoph Gerlinger (DE)
4. Stanislav Katina (CZ)
5. Christos Nakas (GR, CH)
6. Martin Schumacher (DE)
7. Jørgen Seldrup (FR)
8. Jonathan Siegel (USA) +
9. Juan Torres (ES, CH)
10. Chris Weir (UK)
+ New member; Resigned: Thomas Jaki (UK )

3. SiRA: Report
SiRA Sc commented on the FDA Draft Guidance on “Rare Diseases: Common Issues in Drug Development” in October
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 The collection of comments from ISCB was terminated in July Comments were received from five members (Ralf Bender [IQWIG, DE] ; Sorana Bolboacăr [Iuliu Haţieganu 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 on 12 August 2016 to collect comments by 15 December