Introduces safety and surveillance/pharmacovigilance regulations and principles for drugs, biologics, and medical devices across the therapeutic product life cycle. Studies safety/pharmacovigilance-related regulations and guidance from the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory authorities, as well as the role of multidisciplinary, global organizations in developing and harmonizing safety-related best practices. Studies adoption of a life-cycle perspective, beginning with the design of preclinical safety studies and their application to the design of clinical studies, continuing through clinical development and postmarketing. Examines safety and pharmacovigilance in the context of stand-alone and combination therapeutic products, the incorporation of safety information in regulatory documentation, safety data analysis, safety-related quality management, corrective and preventive actions, and regional and global safety initiatives.