Introduction to Safety Sciences

Catalog description

Introduces safety and surveillance regulations and principles for products developed and commercialized in regulated industries. Covers global safety regulations as well as related guidance from agencies such as the FDA, International Conference on Harmonization (ICH), the World Health Organization (WHO), and the European Commission (EC). Adopts a life-cycle perspective, beginning with use of precommercialization data to anticipate human safety issues, and continuing through prototype development and postmarketing issues. Offers students an opportunity to review combination products; safety information in regulatory documents (for example, INDs, clinical study reports, NDA submissions); safety data analysis; quality management and CAPAs; safety plans; and global safety initiatives (e.g., the General Data Protection Regulation).