CMC Strategy Forums

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CMC Strategy Fora

The CMC Strategy Forum is a leading scientific meeting that convenes regulatory, industry, and academic experts to address emerging CMC issues in biotechnology through open, transparent workshops. The Forum explores critical topics that define the biotech industry’s challenges, emphasizing CMC issues across a product's lifecycle. The CMC Strategy Forum works with industry and regulatory agencies to harmonize scientific and regulatory practices. The Forum series had its beginning in the US in 2002 with roughly three Fora being held each year, two in conjunction with the WCBP Symposium in January and one in July. To date, more than 40 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 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. CASSS has also organized the CMC Strategy Forum Japan since 2012 with strong support from the Pharmaceuticals and Medical Devices Agency (PMDA). This program has also received 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, to launch the CMC Strategy Forum Latin America in 2014. Most recently, the Forum was taken virtually and in-person to China in 2021 for the CMC Strategy Forum China.  

The success of the Forum series around the world 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.

Want more information? Contact Carolyn Slade.

Review Resources

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Access approved content from past meetings in the NEW CASSS On Demand platform. CASSS members have access to all available presentation recordings. Visit https://ondemand.casss.org, login to your account, and select from the list of meetings to begin.

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