Statistics in Regulatory Affairs (SiRA)
Members and Terms of Reference
Title & Email
Statistics in Regulatory Affairs
Terms of Reference
The Subcommittee on Regulatory Affairs will review, comment upon and seek to influence the development of regulatory requirements, guidelines and other documents by obtaining the recommendations of ISCB members (SiRA process). This primarily concerns 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. Here the approval refers to the SiRA process for gathering the recommendations of the ISCB members and not the content of those recommendations.
Members
Chair:
1. Stanislav Katina (CZ)
Secretary:
2. Nicole Close (US)
Members:
3. Pascal Roy (FR)
4. Milada Hagen (NO)*
5. Erik Cobo (ES)
6. Harald Binder (DE)
7. Jonathan Siegel (US)
8. Juan Vicente Torres‑Martin (ES)
9. Ralf Bender (DE)
10. Tim Friede (DE)
* President’s Representative
For more details about Statistics in Regulatory Affairs please contact us at this e-mail.
Covid-19 Guidelines 2020
Date (pdf link)
Title (article link)
Wikipedia Initiative: Guidances for Statistics in Regulatory Affairs
Document | Author(s), Date |
Abstract, ISCB37 Birmingham | ISCB SiRA, 2016-03-21 |
Poster, ISCB37 Birmingham | ISCB SiRA, 2016-08-19 |
Abstract, ISCB38 Vigo | ISCB SiRA, 2017-02-13 |
Poster, ISCB38 Vigo | ISCB SiRA, 2017-06-29 |
User Guide | ISCB SiRA, 2017-06-19 |
Paper | ISCB SiRA, 2018-03-07 |
Wikipedia Page | |
Wikipedia List of Guidances |
Comments made on Various Guidelines
Links to Regulatory Guidance Websites
FDA
To check for updates, please use this link for all Clinical/Medical FDA Guidances:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064981.htm
For Medical Devices they separate Draft Guidances from Final Guidances:
Draft are located here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm407274.htm
Final versions are located here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081752.htm
EMA
Use this link to see the status of EMA’s Scientific Guidelines:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb