Overview of the Drug Development Process

Guiding a new product through the stages of research, development, clinical trials and submission of an IND and New Product Marketing Application requires the input of nearly every area within a pharmaceutical company. This course presents a road map for taking the product from bench-scale operations in the research laboratory to full-scale manufacturing production and the requirements for GMP product approval. Pitfalls will be discussed and consideration will be given to the regulatory and quality requirements at each step.