Sponsor or Organizer: Extension Services in Pharmacy, University of Wisconsin-Madison

Description: The purpose of this 4 ½ day University of Wisconsin short course is to provide the learner a survey of the process of non-clinical drug development from lead molecule characterization and preclinical evaluation, to the FDA approval of a new drug product. Within this context, the learner will become familiar with the key science and technologies that support the drug development process. The course will use examples for both small and large molecules and will address issues from discovery to NDA/BLA filings. This unique course features two tracks, one focusing on CMC issues and a second on the biology side of drug development. In each track, the course looks at the scientific and regulatory requirements as well as the interaction required by all stakeholders in the technical development of a new drug entity and their activities as driven by regulatory requirements.

Dates: 04/20/2009

Location: Madison, WI, USA