Program:
FDA/CBER has moved steadily forward since December 1995 to modify the regulations governing
the manufacture of certain biologicals. These regulations covering "specified" biologicals , formerly
known as well characterized biologicals, are causing significant change in the pharmaceutical industry.
The shift from process documentation to product documentation has caused the industry to place far
more emphasis on improving product characterization. This conference is designed to assess what
the industry has learned over the past year. Emphasis will be given to the strategic and tactical
implications of these FDA changes. Case studies from companies that have gone through the CBER
specified biologicals designation process are planned. In addition, specific issues associated with the
product development cycle, intellectual property protection, and product liability will be discussed.
Registration :
Cambridge Healthtech Institute
1037 Chestnut Street
Newton Upper Falls, MA 02164 USA
Phone: 617-630-1300
Fax: 617-630-1325
Deadline for Abstracts: September 12, 1997
Email for Requests and Registration: symposia@cambridge.org