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CMC Forum Japan 2017: Introduction
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The CMC Strategy Forum has established an excellent reputation for being the premier scientific meeting that brings together regulatory, industry and academic professionals to discuss key emerging CMC issues that affect Biotechnology in an open and transparent workshop format. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion. The Forums focus on relevant CMC issues throughout the lifecycle of a product and thereby fosters collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. The Forum had its beginning in the US in 2002, and we are now well into our 35th meeting this year, with roughly three Forums being held each year, two in conjunction with the “Well-Characterized Biotechnology Products” (WCBP) conference series in January and one typically in July near the US Food and Drug Administration campus located in Silver Spring, Maryland. To date, more than 25 peer reviewed publications with industry and FDA co-authorship have resulted from these productive meetings.

Following on the growing interest in the CMC Forum globally, a CMC Forum Europe series was launched in 2007 in Brussels, and rapidly became a very successful annual event that drew regulators and industry professionals across Europe, with the 10th anniversary Europe Forum being planned for Paris in May 2016. The CMC Strategy Forum Europe is aimed at fostering global interactions and harmonization. We have we organized the CMC Strategy Forum Japan for the past four ears (2012 - 2015) with strong support from the Pharmaceuticals and Medical Devices Agency (PMDA). The 5th CMC Strategy Forum Japan will be held 5-6 December 2016, once again in Tokyo. More recently, the inaugural CMC Strategy Forum Latin America was held in August 2014 with great feedback and broad engagement. The 3rd CMC Strategy Forum Latin America will be held in Mexcio City, 5-6 September 2016 with strong support from  Latin American regulatory agencies.

The success of the Forum series in the United States, Europe, Japan and Latin America further demonstrates the benefits and need for providing an open forum for dialogue and exchange of scientific and technical advances that are the basis for evolution of regulatory practices.


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