Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.

Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.

Understanding of the drug development process includes:

• 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

Michael A. Pierro