Sponsor or Organizer: American Chemical Society

Description: Course Code: PROC

This course on pharmaceutical process research will focus on the design and development of practical syntheses for product candidates. The importance of combining synthetic organic chemistry with physical/mechanistic organic chemistry and innovation is stressed. It is designed to expose participants to all phases of drug process development from preclinical to New Drug Application filing. Numerous examples will be used to illustrate key aspects of process research, including issues related to U.S. Good Manufacturing and Good Laboratory Practices (cGMP/GLP) as well as those related to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Real life examples will address creativity, timeline, economic, environmental, analytical, formulation, final form, cGMP, impurity and regulatory issues.

Dates: 02/14/2008

Location: Iselin, NJ, USA