Global Business and Regulatory Working Group (GBRWG)
Purpose
- Develop a practical framework to assist SAFE-BioPharma members in implementation of the SAFE-BioPharma standard
- Provide ongoing support for existing compliance efforts
- Develop and discuss use cases
- Primary focus is on Regulatory, Compliance, Use Cases, Pilots, and Demos of systems.
Participation
- Any Member can participate. Generally Regulatory and Business staff attend, but is open to anyone who wants to participate.
Frequency
- Meets monthly (second Thursday) via teleconference at 11:00AM EST
Chair: Skip Garrison, Forest Labs
Co-Chair: vacant
SAFE-BioPharma EU Advisory Council (SEUAC)
Purpose
- Discuss items of specific interest to European stakeholders with a focus on issues and implementations of Digital Signatures and Digital Identities
Participation
- All European member firms, vendor partners, and Global Business and Regulatory Working Group representatives may participate
Frequency
- Meets monthly or bi-monthly via teleconference
- Meetings are scheduled by the working group members on an as-needed basis
Chair: Isabelle Davias, sanofi
Co-chair: vacant
Technical Working Group (TWG)
Purpose
- Discuss technical aspects of digital signatures and digital identities
Participation
- All member firms and vendor partners may participate
- Presentations on new technology encouraged from vendor partners
Frequency
- Meets monthly (third Wednesday) via teleconference at 10:00AM EST
Chair: Keith Respass, Merck
Operations Services Group (OSUG)
Purpose
- Discuss RAS (Registration Authority System) improvements
Participation
- All firms using the RAS may participate, as does Verizon, the RAS service-provider
- member firms currently using RAS are entitled to one voting representative
Frequency
- Meets monthly (second Wednesday) via teleconference at 10:00AM EST
Chair: Tom Boone, Pfizer
Co-Chair: Ann Plappert, Sanofi
Federation Working Group (FWG)
Purpose
- Discuss technical aspects of using Federation to enable digital identities to be used to access other entities systems.
Participation
- All member firms and vendor partners may participate
- Presentations on new Federation technology encouraged from vendor partners
Frequency
- Meets monthly (Fourth Wednesday) via teleconference at 10:00AM EST
Chair: John Tryon, Merck
Change Control Board (CCB)
Purpose
- Approve changes to the Registration Authority System (RAS)
Participation
- Limited - the designated team that approves production changes to the RAS in accordance with the Change Control Policy
- OSUG Chair represents members
Frequency
- Meets monthly (first Wednesday) via teleconference at 2:00PM EST
