Aegate Continues to Demonstrate Expertise in US Falsified Medicine Detection Ahead of DQSA Act Implementation

London and Washington D.c. (ots/PRNewswire) -

Aegate, the world's leading provider of medicines authentication
services, continues to fulfil its commitment to support all
stakeholders in the healthcare value chain in the swift achievement
of the Drug Quality and Security Act (DQSA) compliance within the
mandated adoption period by sharing its expertise with its growing
network of ecosystem partners and users.

The first and only medicines authentication provider to provide a
validated hospital authentication service, Aegate shared its
experience captured in the Good Authentication Practice (GAP(TM)) (ht
tp://ejhp.bmj.com/content/early/2015/10/01/ejhpharm-2015-000750.short
?rss=1) protocol, developed in collaboration with the University of
Oxford at the Regulatory Affairs Professionals Society (RAPS) annual
conference held in Baltimore, MD.

Sharing insights, Aegate presented the findings of the secondary
care authentication pilot at the University of Oxford alongside
senior representatives from the Food and Drug Administration (FDA),
European Medicines Agency (EMA), World Health Organization (WHO) and
leading manufacturers as well as the company's substantial experience
of authentication acquired through the delivery of the EU Falsified
Medicines Directive (FMD).

Mark De Simone, CEO of Aegate said:

"Aegate is committed to supporting critical US FDA initiatives,
including the FDA Counterfeit Alert Network. The health of US
citizens and the profitability of the US pharmaceutical industry are
central to the DSQA, and Aegate's long term mission. Aegate is
confident that its expertise in technology, operation and
implementation offers extraordinary value to all stakeholders in the
healthcare value chain that will ultimately reduce cost, increase
profitability and, above all, safeguard patient safety"

Aegate furthered the commitment to promoting stakeholder
understanding through the publication of an expert open access
resource on falsified medicines regulations in collaboration with
leading academics, in the core text for the Regulatory Affairs
Certificate (RAC) examination, Fundamentals of EU Regulatory Affairs
(https://www.raps.org/store/fundamentals-of-eu-regulatory-affairs,-se
venth-edition/70344741).

The company has built more than a decade of technical and
operational experience and in excess of 3.6 billion successful
medicine authentication events in more than ten countries. This
includes successful field tests of its authentication service in the
US.

Aegate's US team will be announcing further initiatives aimed at
supporting stakeholders in achieving DQSA compliance in the coming
months. These will include academic partnerships, an expert advisory
board and accredited service implementation partners, including
primary and secondary care pharmacies.

NOTES TO EDITORS

GAP(TM) is a registered trademark of Aegate Ltd. Full details of
the GAP protocol are available open access via the European Journal
of Hospital Pharmacy: http://ejhp.bmj.com/content/early/2015/10/01/ej
hpharm-2015-000750.short?rss=1

Fundamentals of EU Regulatory Affairs, Seventh Edition:

https://www.raps.org/store/fundamentals-of-eu-regulatory-affairs,-
seventh-edition/70344741

About Aegate

Aegate operates a highly secure real-time service to verify the
authenticity of medicines. This operates seamlessly from manufacturer
to pharmacy, and has been independently certified as reliable, secure
and 100% accurate. Aegate fully meets the requirements of a number
of worldwide legislative efforts to combat falsified medicines,
including the EU Falsified Medicines Directive, and is the only
medicines authentication provider to provide a validated hospital
authentication service, developed in collaboration with the
University of Oxford. Since it was established in 2003, the Aegate
service has checked over 3.6 billion medicine packs and has issued
over 2.5 million individual patient safety alerts to pharmacies
across Europe. Aegate has offices across Europe and North America
with the authentication system operating in over 20,000 dispensing
points.

ots Originaltext: Aegate
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Aegate
Sean O'Connell
T +44-1763-268-160
E prglobal@idbs.com

Edelman
Alec Newton
T +44-203-047-2140
E alec.newton@edelman.com

aegate@edelman.com