CMC Strategy Forums

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 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 40 peer reviewed publications with industry and FDA co-authorship have resulted from these productive meetings.

Hear from our committee members about their CMC Strategy Forum experiences:

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.

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 Dave Bergeson.