About the Event

Workshop overview:

This course provides an overview of how new therapeutic goods are identified and developed. The roles and interactions amongst marketing, clinical research and development (R&D), regulatory affairs, and manufacturing will be reviewed. A basic description of the Australian regulatory framework will lead to a review of how clinical trials are started, completed and reported as well as ethical considerations in conducting clinical research. The course material focuses on developing drugs and biologics under Australian regulations and ICH-GCP guidelines.

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