Obtaining market approval is an important step in the development of a new biomedical product. In this course you’ll learn how to find and interpret the relevant regulatory guidelines that will steer you through the development process. Real-world case studies, including the development of a gene therapy product and a fictitious mRNA-based vaccine, are presented to familiarize you with issues that can arise during development, as well as how to assess an Investigational Medicinal Product Dossier (IMPD).