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CASSS CMC Strategy Forums

CASSS offers five CMC Strategy Forums to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulator interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices.


  CMC North America
   CMC Europe   CMC North America CMC Latin America   CMC Japan

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 Forum had its beginning in the US in 2002, and we are now well into our 50th 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 32 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. The CMC Strategy Forum Europe is aimed at fostering global interactions and harmonization. The 14th meeting of the CMC Strategy Forum Europe will be held 11-13 May 2020 in Stockholm, Sweden. We have organized the CMC Strategy Forum Japan for the past eight years  (2012 - 2019) with strong support from the Pharmaceuticals and Medical Devices Agency (PMDA). The 8th CMC Strategy Forum Japan was held 11-12 December 2019, once again in Tokyo. More recently, with strong support from ANVISA-National Health Surveillance Agency, as well as GrupoFarma Brasil, Interfarma-Association of Pharmaceutical Research and several other Latin America regulatory agencies, the CMC Strategy Forum Latin America was launched in Brasilia, Brazil in 2014 and 2015. The 4th CMC Strategy Forum Latin America was held 12-13 March 2019 in Brasilia, Brazil and we are planning for the 5th CMC Strategy Forum Latin America to be held in August 2020. 

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.

More than 30 years ago, CASSS began as a local, non-profit chromatography discussion group in the San Francisco Bay Area. Over time, our offerings have grown to include multiple North American and international scientific symposia and our members span the globe. While our offerings have expanded, CASSS still aims to provide educational and networking opportunities for scientists in their local area. 

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