Drug development in the USA involves a complex process of research, preclinical testing, clinical trials, and regulatory approval. The process is overseen by the FDA, which sets safety and efficacy standards for drugs. It typically takes over a decade and costs billions of dollars to bring a new drug to market.
This course is designed to deliver students a “big picture” perspective of the entire drug development process in the USA and the scope and functioning of a pharmaceutical company with a focus on drug discovery, product development, and drug safety.
Learning Points:
- Drugs, Drug Development Process, and their Life Cycle
- The Industry Big Picture – Marketing and Science
- Clinical Trials Process and Compliance
- Introduction to Drug Safety, Pharmacovigilance
- Advertising of Drug Products
- Economic Assistance and Incentives for Drug Development
- FDA’s Regulatory requirements
- Recent Breakthroughs