CRC 202Investigational Prdct Develope

Catalog

Overview of investigational product development with attention to the legal and regulatory framework guiding drug and device safety. Includes the principles of Pharmacovigilance and Materiovigilance, including the detection, monitoring, assessment, understanding, and prevention of adverse effects associated with medicines, vaccines, biological and medical device products. Also includes how regulatory oversight supports patient safety and product integrity throughout development.