We are pleased to announce the creation
of the CMC Strategy Forum, A Section of the
CASSS. The
objective of the CMC Strategy Forum is to provide an
environment for the development of technical and
regulatory consensus positions regarding topics of
interest. Consensus positions regarding topics of
interest to will be communicated to the FDA and
Industry through appropriate mechanisms (e.g.,
publications). The CMC Strategy Forum is intended to:
-
Establish a biotechnology industry
forum that focuses on industry and FDA CMC concerns
identified at the annual meeting.
-
Foster collaborative technical and
regulatory interactions that advance discussions to
consensus concepts for our mutual benefit.
-
Provide this information to the FDA to
allow them to merge good scientific practices with good
regulatory practices.
-
Further examine the technical and
regulatory issues raised at meeting and develop
plans to address them.
The Forum will also provide a venue for
discussing the latest bio-molecular methods and their
practical application to biotechnology pharmaceuticals and
other health related products. This includes both method
and instrumental advances that are used for product
characterization, process development, and validated
in-process, release and stability tests.
