CRC202 — Investigational Product Development
3 , 3 lecture periods 0 lab periods 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. Information: Students must be admitted to or have conditional status in the Clinical Research AAS or Post-Degree Certificate program or obtain the consent of the instructor before enrolling in this course. Course Learning