CMC Strategy Forum North America

Defining and Developing Comparability Strategies for Novel and Complex Biotherapeutics | Innovation in the Formulation and Delivery of Biotherapeutics

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 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.
• To provide the information to the FDA to allow them to merge good scientific practices with good regulatory practices for our mutual benefit.

For more information, visit CMC Strategy Forum North America