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The Industry Standard for Digital Trust

The Industry Standard for Digital Trust digital signatures are ” recognized by FDA and EMA. Both agencies have participated in developing the SAFE-BioPharma industry standard

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The Industry Standard for Digital Trust

“ ”While other technologies may work well in particular situations, SAFE-BioPharma provides a greater level of protection. It provides authentication, non-repudiation and data integrity across every single bit.

Randy Sabett, partner Sonnenschein Nath & Rosenthal LLP

Washington, D.C.

Legal Protection

“ ”SAFE-BioPharma digital signatures are recognized by FDA and EMA. Both agencies have participated in developing the SAFE-BioPharma industry standard.

Rich Furr Global Regulatory Affairs and Chief Compliance OfficerSAFE-BioPharma Association

Regulatory Acceptance

“ ”SAFE-BioPharma digital signatures help companies reduce their environmental impact. Lab scientists at one company used more than one-million SAFE-BioPharma digital signatures to reduce paper consumption by 3.3 million pages – the equivalent of 16 tons!

Mollie Shields-UehlingPresident and CEO

SAFE-BioPharma Association

Environmentally Friendly

“ ”Every SAFE-BioPharma digital identity is interoperable with US federal agencies, other companies and other industries. It provides uncompromising digital security in an uncertain digital world.

Gary SecrestDirector, Worldwide Information SecurityJohnson & JohnsonChairman, SAFE-BioPharma Association

Interoperable

“ ”SAFE-BioPharma digital signatures are the last step in eliminating paper from the contracts/budget department of our clinical research investigator site. We will save the time and cost of making, shipping, storing and locating paper copies.

Aaron J. Harned Chief Operating Officer and

Chief Financial OfficerIPS Research Company

Oklahoma City

Paperless

“ ”Access to the SAFE-BioPharma industry standard is one of the great technology bargains of the biopharmaceutical industry. For a pharmaceutical CRO like ours it costs only $50 per user per year.

Janet McDougall, CEOMcDougall Scientific LtdToronto

Economical

Members:

The Authentication Authority

den rust ™

I T

Vendor Partners:

Board of Directors:

Gary Secrest, • SAFE-BioPharma ChairmanDirector, Worldwide Information Security, Johnson & Johnson

Christopher W Baker•Manager, R&D Business Operations, GlaxoSmithKline

William Barnes •Director, Identity Services, Pfizer

Peter Loupos•Vice President, Scientific Information Systems, sanofi-aventis

Terence Rice•Senior Director, Information Security and Networks, Merck

Mollie Shields-Uehling• , President & CEOSAFE-BioPharma Association

Joseph Waldron•Executive Director, Global Development Information, AstraZeneca

Rick Yborra•Vice President, Information Management Shared Services, Bristol-Myers Squibb

The views expressed in this material represent an individual opinion and do not constitute legal advice. Please consult your own legal counsel for any guidance or questions related to use of the SAFE-BioPharma industry standard or any related technology.

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

SAFE-BioPharma® is the industry standard developed to transition the biopharmaceutical and healthcare communities to paperless environments. The SAFE-BioPharma standard is used to verify and manage digital identities involved in elec-tronic transactions and to apply digital signatures to electronic documents. SAFE-BioPharma was developed by a consortium of biopharmaceutical and related companies, with participa-tion from the US Food and Drug Administration and the European Medicines Agency.

www.SAFE-BioPharma.org201-849-4545