Aegate Continues to Demonstrate Expertise in US Falsified Medicine Detection Ahead of DQSA Act Implementation
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)) (http://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,-seventh-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/ejhpharm-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.
Contact:
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Sean O'Connell
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Alec Newton
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aegate@edelman.com