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New Chairman for Global Harmonization Task Force

Quality Digest
Tue, 01/23/2007 - 22:00
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A Food and Drug Administration senior scientist will be the next chairman for the agency’s Global Harmonization Task Force, which was established as an international effort to improve the quality of medical devices and regulatory systems.

Dr. Larry Kessler is director of the office of science and engineering laboratories, which is a division of the FDA’s center for devices and radiological health. He assumed the chairmanship in December and will hold the position for 18 months.

Since it was founded in 1992, the GHTF has issued almost 40 harmonized guidance documents designed to help developing countries implement effective regulatory systems for medical devices and pharmaceutical manufacturing.

Kessler was chairman of a GHTF study group from 1996 to 2000 that reviewed post-marketing surveillance of medical devices in the task force’s founding countries, which include the United States, Japan, Canada and Australia. The study group also produced major documents that helped establish a harmonized, international system of reporting adverse events associated with medical devices.

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