New professional society journal article reviews current state of global regulatory harmonization initiatives and the GHTF.
FRAMINGHAM, MA – April 1, 2007 – 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 “Going Global: Taking a World View” is published in the April, 2007 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses the global regulatory harmonization initiatives, including harmonization of medical device classification schema. It also reviews the Global Harmonization Task Force (GHTF) structure, goals, study group organization, and accomplishments to date. Recommendations for global market clearance are also given.
The article is coauthored by Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc. and Michael Chang, RAC, clinivation, Inc.
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