Event Date/Time: Nov 05, 2007
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End Date/Time: Nov 05, 2007 |
Description
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA.
The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines.
Venue