New professional society journal article reviews the current state and outlook on harmonization of medical device regulations worldwide.
NATICK, MA – June 1, 2008 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation thought leaders in the areas of global market clearance operations and regulatory affairs.
The article entitled “Global Harmonization: Achieving New Levels of International Cooperation” is published in the June, 2008 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses the current state and outlook on harmonization initiatives underway at the U.S. FDA, the Global Harmonization Task Force (GHTF), the Asia Harmonization Working Party (AHWP), and other groups. It also reviews the benefits and obstacles faced in worldwide harmonization of medical device regulations.
The article is coauthored by Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc. and Taras Bouzakine, RAC, CQPA, clinivation, Inc.
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