CMC Strategy Forum North America 

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 United States in 2002, with three Forums now being held each year. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion on relevant CMC issues throughout the lifecycle of a product. The outcomes of the Forums are: 

  • To foster collaborative technical and regulatory interactions that advance discussions to consensus concepts; and
  • To provide the information to the Regulatory Agency to allow them to merge good scientific practices with good regulatory practices for our mutual benefit.

The success of the Forum series further demonstrates the benefits and the need for providing an open forum for dialogue and exchange of scientific and technical advances that are the basis for evolution of regulatory practices.

For more information, visit the CMC Strategy Forum North America Site

Click on the tab below to view Speaker Presentations from the most recent meeting, as well as all Summary Papers. 

 

CMC North America Summary Papers

Review Resources

Want to revisit a keynote presentation? Missed important details that may impact your work?

Visit Papers and Presentations to access relevant presentations, summary papers, and roundtable notes.