Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Astellas Pharma Inc. Is First Japanese Pharma Company to Join SAFE-BioPharma

Published: Thursday, June 20, 2013
Last Updated: Thursday, June 20, 2013
Bookmark and Share
SAFE-BioPharma Association is responsible for the ongoing development and implementation of the global SAFE-BioPharma® digital identity and signature standard.

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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Astellas Pharma and Daiichi Sankyo Form Compound Library Sharing Partnership
Both Companies will exchange approximately 400,000 selected compounds.
Saturday, March 22, 2014
Astellas to Form Strategic Partnership with ClearPath to Build Vaccine Portfolio
In-license vaccine technology for respiratory syncytial virus (RSV) from Mymetics.
Tuesday, January 07, 2014
Scientific News
Advanced Lymphoma in Remission After T-Cell Therapy
63% of trial participants who recieved two-drug combination chemo plus intermediate dose of engineered T cells went into complete remission.
New Treatment for Immune Cancers
Clinical trial shows new drug holds promise for treating advanced mastocytosis.
Sickle Cell Gene Therapy Passes Test
Researchers found a precision-engineered gene therapy virus reduced sickle-induced red-cell damage in mice with sickle cell disease.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Inovio Launches Zika Vaccine Trial
Inovio launches Zika vaccine trial in midst of Puerto Rico epidemic to explore early signals of vaccine efficacy.
Vitamin C May Boost Leukemia Treatment
Studies show that supplementing an epigenetic cancer drug with vitamin C enhanced the drug's effectiveness.
New Hope for Zika Treatment Found in Large-Scale Screen of Existing Drugs
Johns Hopkins researchers join collaborative group to screen 6,000 existing drugs in hopes of finding treatments for Zika Virus infection
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!