The Drug Development Process - From Discovery to Commercialization 2012

This course provides an understanding of the interrelated activities throughout the drug development cycle and is designed for R&D, operations and/or marketing and sales management. This course serves as an introduction to the drug development process and will familiarize participants with the steps involved in developing a drug from Discovery to Commercialization. The course is often customized to address specific organizational, departmental or functional issues.

Topics include:

-Basic concepts of drug discovery and testing
-Scientific, regulatory, and management framework for modern pharmaceutical development
-Pre-clinical study requirements and how information gathered is used for human clinical studies
-The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase
-The economics of drug development
-Cost/benefit issues in clinical development
-Discovery and development milestones
-The IND Process
-The NDA Process
-FDA Interactions – Application review and approval process
-Patents and exclusivity
-The rationale of government regulations and how they effect the development process
-The relationship between the Code of Federal Regulations and ICH GCP
-Designing optimal clinical trials
-Drug labeling, marketing, and pharmacoeconomic studies
-Project management cross functional teams during the development process