The course describes the evolution of the regulations that govern the pharmaceutical industry and examines how the resultant regulatory framework influences and guides pharmaceutical companies in the development, manufacture, testing and commercial distribution of drugs. Multiple aspects in the drug development process influenced by the regulations including quality system design and operation, regulatory affairs group structure and activities, compliance, good practices (GxPs), and ethics will be covered. The course will explore the global regulatory environment but will focus on the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as primary study cases when examining the regulations, processes and controls for clinical development, marketing authorization approvals and post-approval changes for drugs, biologics and vaccines.
CH 563: Drug Regulations and Regulatory Affairs
Department