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.
Course Number: BIOL-40015
Credit: 3.00 unit(s)
Related Certificate Programs: Drug Discovery and Development
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3/29/2021 - 5/31/2021