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SYS-CON MEDIA Authors: JP Morgenthal, AppDynamics Blog, John Wetherill, Harry Trott, Roger Strukhoff

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Recipients of 2013 SAFE-BioPharma “DIGI” Awards Named

The European Medicines Agency is one of six recipients of the just announced 2013 SAFE-BioPharma DIGI Awards. EMA was selected for requiring use of digital signatures on certain regulatory submissions, as well as on all of its outgoing Internet correspondence.

The DIGI is presented annually to recognize the institutions and individuals contributing to broader use and understanding of the global SAFE-BioPharma® digital identity and digital signature standard, which is improving the efficiency and accuracy of life science business processes through more secure and private electronic transactions. Companies utilizing services and technologies supporting the SAFE-BioPharma standard are able to eliminate inefficient paper-based processes and replace multiple electronic identities with a single, secure digital identity, which can be used with all partners and is trusted by all U.S. government agencies. EMA and the FDA participated in developing the SAFE-BioPharma standard.

“The selected entities have made real advances in the use of the SAFE-BioPharma standard," said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.

Award recipients follow:

New advances in regulatory acceptance

  • European Medicines Agency, which announced in 2013 that it requires use of EU-qualified digital signatures for certain submissions. This new policy is in line with EMA’s strategy for a “future electronic only workflow” between itself and the pharmaceutical industry by eliminating the need and cost associated with printing, sending and archiving paper documents. Digital signatures based on the SAFE-BioPharma standard meet all EU criteria. EMA also announced it “…will start to use digital signatures systematically in outgoing documents that currently require a legally binding signature.”

Innovative implementation of the SAFE-BioPharma standard

  • Astellas Pharma, Inc. for its use of SAFE-BioPharma identity credentials for a variety of processes, including certifying documents associated with case processing in pharmacovigilance.

Innovative product compliance

  • DocuSign, which created a comprehensive electronic and digital signature solution integrated with the global SAFE-BioPharma digital signature standard. The solution provides end-to-end paperless workflow capabilities that are easily customized to users’ needs. Healthcare and life science organizations can use the solution to become fully paperless, while complying with all regulatory and other compliance requirements.

Global Expansion

  • Arxspan, LLC, for integrating the SAFE-BioPharma standard into its cloud-based electronic laboratory notebook product, ArxLab, and using it successfully on behalf of a major U.S. pharmaceutical company to deploy and manage mobile-based digital identity credentials for scientists working in Chinese contract research organizations. The scientists there use the credentials to apply digital signatures to electronic laboratory notebooks.

Visionary Outlook

  • Cegedim Relationship Management, for its plans to issue SAFE-BioPharma identity credentials to healthcare professionals participating in Docnet, its secure online professionals' social network, allowing life science personnel to digitally engage in a variety of services, including co-pay assistance, surveys, pre-disclosure spend reporting and peer-to-peer networking. Docnet has 7 million+ healthcare professional profiles available and offers access on any device, allowing them to make connections and join private groups to share information in a secure setting anytime and anywhere.

Journalistic Reporting

  • World Pharmaceutical Frontiers magazine, for featuring the SAFE-BioPharma standard in a series of feature articles, with titles including "The Birth of Cyber-Collaboration" and "Identity Trust in Cyberspace."

About SAFE-BioPharma

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the U.S. Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development are managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org.

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

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