PHILADELPHIA, Sept. 25, 2024 -- Rx-360® is pleased to announce that it has been accepted as a Pilot Center of Excellence (CoE) for the APEC Regulatory Harmonization Steering Committee. The pilot will be focused on the Global Medical Product Supply Chain Integrity Priority Work Area Roadmap. As an international non-profit, with a mission based on pharmaceutical supply chain integrity, material quality, and patient safety, Rx-360® will be able to bring its 15 years of experience to help drive the mission of Asia Pacific Economic Cooperation (APEC).
Jim Fries, CEO of Rx-360 commented, "This is a tremendous honor for our consortium to be able serve the APEC mission around medical product safety. We look forward to working with the other Centers of Excellence, US Pharmacopeia, and Taylor's University in Malaysia, to enhance the already great educational offerings available to the industry."
Economies are adversely impacted by the international movement of substandard and falsified medical products. As the medical products industry has become more globalized and specialized, APEC economies are faced with many challenges in keeping citizens healthy, while ensuring that access to legitimate products is not disrupted. To address this issue, the Roadmap for Global Medical Product Quality and Supply Chain Security project (Roadmap) was developed. The Roadmap was a multi-year effort commissioned by APEC with oversight by the Regulatory Harmonization Steering Committee (RHSC). It became a priority work area (PWA) in APEC, bringing together regulators, industry members, academics, and other stakeholders from across the APEC economies, and EU, Africa, and other parts of South America. This work culminated in the development of the Supply Chain Security Toolkit (Toolkit) in 2017. The Toolkit contains training materials intended to educate regulators, industry members, and others on a particular part of the supply chain, including its best practices, guidance documents, etc. The Toolkit includes ten (10) work streams, covering the entire supply chain and life cycle of medical products. This Toolkit will be the focus of educational workshops and relevant training designed and offered by Rx-360 as part of the pilot CoE.
About Rx-360:
Rx-360, an international pharmaceutical supply chain consortium, was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The organization's mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain. To learn more about Rx-360, please visit http://www.Rx-360.org or email jfries@rx-360.org.
About APEC Regulatory Harmonization Steering Committee:
The Regulatory Harmonization Steering Committee (RHSC) was formed in June 2009 under the auspices of APEC to promote a strategic approach to regulatory harmonization by undertaking activities of greatest value to regulatory authorities and regulated industries. It is a network of regulatory experts from regulatory agencies in APEC economies, industry and academia with the vision of achieving greater regulatory convergence within the APEC economies by 2020. The RHSC does not seek to develop new guidances but is designed to play a complementary role to other regional international regulatory initiatives.
Contact: James Fries, jfries@rx-360.org
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