Astellas Pharma Inc. Is First Japanese Pharma Company to Join SAFE-BioPharma
News Jun 20, 2013
As a member of the association, Astellas is able to utilize the SAFE-BioPharma standard throughout its operations. It is the first Japanese pharmaceutical company to become a SAFE-BioPharma member.
Digital identity credentials compliant with the SAFE-BioPharma standard are used to manage cyber-identities in the biopharmaceutical and healthcare sectors and to apply a higher form of electronic signature to electronic documents.
SAFE-BioPharma identity credentials will be used in several ways across the organization including application of digital signatures to submission documents for FDA and EU regulatory agencies and on a full range of clinical documents. Astellas also will use SAFE-BioPharma identity credentials for a variety of processes such as certifying scanned documents associated with case processing, computerized system validation for IT systems, and for change management procedures.
In addition to Astellas, SAFE-BioPharma pharmaceutical members include Abbott, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Merck, Pfizer, Roche and Sanofi.
“We welcome Astellas to the expanding community of organizations using the SAFE-BioPharma standard. Their use of the standard will help improve productivity, cost reduction, and time to market by moving their processes more completely online,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.
In 2012, Astellas Pharma was a winner of the SAFE-BioPharma “Digi” Award in global expansion for its innovative use of SAFE-BioPharma digital signatures in a virtual clinical process pilot project in Japan.
The SAFE-BioPharma standard was created by the biopharmaceutical industry to provide standardized, high-assurance identity trust for cyber-transactions. The US CIO Council, the FDA and the EU EMA participate in the standard’s ongoing development. Among its rules and regulations, the standard requires a close bond between the user’s cyber-identity and actual identity. Digital signatures based on the standard are more secure and legally binding than conventional electronic signatures and are recognized by regulatory agencies throughout the U.S. and Europe.
The identity resides in a computer, token, or, increasingly, in a highly-secure hardware module in the cloud and, in addition to applying signatures, is used for authorized access to information stored behind company gateways, portals and firewalls.
U.S. Study of Dapivirine Ring in Lactating Women Finds Little Drug Gets Into Breast MilkNews
The antiretroviral drug dapivirine that is released from an experimental vaginal ring to protect against HIV is absorbed in very low concentrations into breastmilk.READ MORE
Cell Recycling System Offers Therapeutic Entry Point for Rare Disease TreatmentNews
Scientists have demonstrated how an investigational drug works against a rare, fatal genetic disease, Niemann-Pick type C1 (NPC1).READ MORE
Bone Cancer Drug Targets Tumors, Spares Other OrgansNews
A study led by The University of Texas MD Anderson Cancer Center found a drug known as bone metastasis-targeting peptidomimetic (BMTP-11) has potential as a new therapeutic strategy for this devastating illness.READ MORE
Comments | 0 ADD COMMENT
EMBL Conference: European Conference of Life Science Funders and Foundations
Apr 19 - Apr 20, 2018
EMBL Course: Target Engagement in Biology and Drug Discovery
Feb 19 - Feb 23, 2018