Introduction to Safety Sciences

RGA 6212 4 Quarter Hours
Course Level CPS - Graduate
Description 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).

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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