TENAFLY, N.J. -- (BUSINESS WIRE) --
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
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
Innovative implementation of the SAFE-BioPharma standard
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
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
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.
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
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
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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