Recipients of 2013 SAFE-BioPharma “DIGI” Awards Named
Includes European Medicines Agency and Japanese Pharmaceutical Company
TENAFLY, N.J. -- April 3, 2014
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,
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
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.
*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
*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.
*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."
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
SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this
trademark requires approval from SAFE-BioPharma Association.
Jon Weisberg, 801-359-9977
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