Safety Sciences 1: Introduction to Safety and Surveillance
RGA6212 / 4 q.h.
Formerly RA 3212.
Introduces safety and surveillance regulations and principles for drugs, biologics, and medical devices. Offers students an opportunity to become familiar with the U.S. and global safety regulations, as well as related guidance from FDA, ICH, WHO, and CIOMS. Adopts a life-cycle perspective, beginning with use of preclinical data to anticipate human safety issues and continuing through clinical development and postmarketing. Examines combination products, safety information in regulatory documents (INDs, clinical study reports, NDA submissions), safety data analysis, quality management and CAPAs, and global safety initiatives (e.g., the WHO Uppsala Monitoring Centre). Prereq. RGA 6100, RGA 6201, or RGA 6202.
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