Program:
The biotechnology industry assembled in Washington, DC last December to listen to the FDA discuss its intentions to modify the regulations governing the manufacture of biologicals. These new regulations covering well characterized biologicals should cause significant change in the pharmaceutical industry. The shift from process documentation to product documentation will cause the industry to place more emphasis on improved product characterization. This conference is designed to assess what the industry heard at the December FDA meeting. Emphasis will be given to the strategic and tactical implications these FDA changes pose for specific steps in the product development cycle, intellectual property protection and product marketing. Advances in analytical technologies related to process monitoring and control as well as product verification will also be the focus of the third day.
Registration :
Cambridge Healthtech Institute
1037 Chestnut Street
Newton Upper Falls, MA 02164 USA
tel: 617-630-1300
fax: 617-630-1325
Deadline for Abstracts: 9/96
Email for Requests and Registration: chi@healthtech.com