BURLINGAME, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- Accumulus Synergy, Inc. (“Accumulus”), a nonprofit industry association enhancing data exchange for the life sciences-regulatory industry, is proud to share a newly published global standard for the exchange of Pharmaceutical Quality (PQ) data: the Fast Healthcare Interoperability Resources (FHIR®) Implementation Guide for PQ (Industry) data standard.

As the life sciences-regulatory industry continues its digital transformation journey, efficient data exchange remains a critical challenge. PQ content is reused throughout the medicinal product lifecycle accounting for the majority of information exchanged across organizations. In response to this challenge, Accumulus Synergy sponsored the initiative on behalf of industry at large leveraging Health Level Seven International’s (HL7) next-generation standard, FHIR®, to streamline data exchange and collaboration. This harmonized, structured international data standard will expedite the preparation of global regulatory filings and reduce the time to exchange data from hours and days to minutes and, eventually, seconds.

“Our sponsorship of the PQ (Industry) data standard is an example of our active partnership within the regulatory ecosystem to help shape policy and raise awareness to positively impact public health,” commented Frank Nogueira, Accumulus Chief Executive Officer. “As an industry association, we have both an opportunity and a responsibility to help shape data standardization and harmonization, ultimately propelling the industry toward a fully data-driven global dossier in the cloud. Coupled with the recent launch of our collaboration and data exchange platform, we are pushing the boundaries of what is possible.”

Accumulus remains committed to supporting the expansion and adoption of the PQ (Industry) standard as a means of advancing the regulatory ecosystem, and encourages organizations to unite around this structured, standardized approach for information exchange.

“This is a landmark milestone for the biopharmaceutical industry and a critical step forward in our digital transformation journey,” said Rita Algorri, Amgen Senior Manager, Global Regulatory Affairs and Sponsor member of the Accumulus Quality/Chemistry, Manufacturing and Controls Task Force. “Pharmaceutical Quality (Industry), as the first PQ data standard, sets the foundation for the future of data exchange across industry.”

Facilitating generative AI, content reuse, and real-time data exchange, the newly published standard promises to have a profound effect on innovation and creativity. Commenting on the achievement, Michael Abernathy, Amgen Executive Director, Global Regulatory Affairs and Sponsor member of the Accumulus Quality/Chemistry, Manufacturing and Controls Task Force said, “Our industry now has access to a common PQ taxonomy, enabling us to leverage 21st Century digital technologies with the ambition to achieve real-time data exchange within a global cloud-based ecosystem. This is a gamechanger for the biopharmaceutical industry and for patients around the globe.”

To learn more about the FHIR® Implementation Guide and explore collaboration opportunities, please visit Pharmaceutical Quality (Industry). For more information about the creation of this standard, visit PQ (Industry) Data Standard White Paper or email [email protected].

About Accumulus Synergy
Accumulus Synergy is a global, nonprofit industry association developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global Regulatory Authorities, while also affording users the ability to extract dynamic, data-driven insights. Accumulus is working with key stakeholders in the life sciences – regulatory ecosystem to build and sustain a platform that aims to meet regulatory, cybersecurity, and privacy requirements spanning clinical, safety, chemistry and manufacturing, and regulatory exchanges and submissions. Accumulus Synergy Sponsors include 12 leading global pharmaceutical companies.

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