Regulatory Panel to Discuss the Evolving Regulatory Process for Digital Pathology Products in the U.S.

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A panel of experts will lend new insights into the evolving regulatory process for digital pathology products at the Digital Pathology Association Pathology Visions Conference Oct. 30 – Nov. 2 in San Diego, CA. The regulatory panel session will bring together representatives from the Food and Drug Administration, Centers for Medicare and Medicaid Services, and College of American Pathologists to discuss the regulatory path for digital pathology in the U.S. Panelists will present and discuss the roles and current thinking of their organizations regarding the evaluation and adoption of digital pathology. Plus, a White Paper presentation on the archival and retrieval of images and associated data in digital pathology will be discussed during the Town Hall Meeting at the international conference.

A panel of experts will lend new insights into the evolving regulatory process for digital pathology products at the 2011 Pathology Visions Conference. The regulatory panel session will bring together representatives from the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), and College of American Pathologists (CAP) to discuss the regulatory path for digital pathology in the U.S. The panel discussion will cap off the Digital Pathology Associations’ (DPA) Pathology Visions Conference Oct. 30 – Nov. 2 in San Diego, CA.

The panel session will be led by Dr. Stephen Hewitt, NCI and a member of the 2009 FDA Hematology and Pathology Devices Advisory Panel on Digital Pathology. Each panelist will present and discuss the roles and current thinking of their organizations regarding the evaluation and adoption of digital pathology in its many forms and applications.

The panelists include: Tremel Faison, MS, RAC, SCT (ASCP) representing the FDA Office of In Vitro Diagnostic Device Evaluation and Safety; Walter Henricks, M.D., Cleveland Clinic, representing the CAP Laboratory Accreditation Program and the CAP Quality Center Work Group on whole slide imaging systems; and Debra Sydnor representing the CMS Division of Laboratory Services (overseeing CLIA).

“The regulatory panel session at Pathology Visions will provide frank and open discussion of the shared roles pathologists, FDA, CMS, CAP and device manufacturers must play to allow efficient and effective exploration of the promise of digital pathology for the advancement of medical research and the enhancement of clinical diagnostics,” said Laura M. Ferguson, Ph.D., Chair of the Digital Pathology Regulatory Task Force and Group Manager Market Strategy, Olympus America Inc.

“The DPA is please to assemble this distinguished panel of experts to discuss the evolving regulatory process for digital pathology products,” said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. “This session complements the many excellent speakers who will discuss clinical, research and educational applications of digital pathology, and provides an important perspective for anyone involved in digital pathology in the U.S.”

The Regulatory Panel discussion will be held on the final day of the Pathology Visions Conference, Nov. 2 from noon – 2pm. To be a part of the historic conversation register for the conference today.

Pathology Visions attendees will also learn more about the issues surrounding the archival and retrieval of images and associated data in digital pathology and how labs and vendors are working to assist.

Ole Eichhorn, Chief Technology Officer with Aperio, will discuss the demand on digital pathology systems to provide labs with reliable, flexible and secure ways to store, manage and retrieve whole slide images along with associated case meta-data. The Archival and Retrieval in Digital Pathology White Paper will be one of three papers to be presented at the Town Hall Meeting at the conference.

More than 40 distinguished industry experts will present at the Pathology Visions Conference and physician attendees can earn up to 13 CME credits for attending any of the clinical, research or educational speaker presentations. Conference attendees will also have access to cutting-edge industry workshops covering innovative topics in digital pathology, scientific poster sessions, roundtable discussions, the latest product solutions, and networking events.

The conference is geared toward all types of healthcare professionals and service providers interested in learning about digital pathology solutions and deployment strategies.

About the DPA: The mission of the Digital Pathology Association is to facilitate education and awareness of digital pathology applications in healthcare and life sciences. Members will be encouraged to share best practices and promote the use of the technology among colleagues in order to demonstrate efficiencies, awareness, and its ultimate benefits to patient care.

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