BIOT 216Risk Management for Drugs and Medical Devices

Catalog

Prerequisites:BIOT 214 - Food and Drug Law or BIOT 215 - Clinical Trials; or Program Advisor Approval. Corequisites: Pre/Corequisites: Description:This course provides an introduction to risk management as outlined in ISO 14971 ISO 13485, and ICH Q8, Q9, and Q10, which are recognized standards by most Western Medicinal Products Safety Agencies responsible for regulating medicinal products. Students will learn by applying knowledge gained from standards, guidance documents, and FDA regulations, as well as www.FDA.gov website search skills in working through 3 FDA case studies that look at regulatory pathways to US marketplace, safety assurance case for a medical device, and bringing an innovative medical device to US marketplace via premarket approval.