Description
This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to maintain and gain approval to market medicinal products in Europe and the USA. The roles of major players and legal framework are presented.
Also outlined is the life-cycle of a drug. The multiple procedures available for approval and assessment of products are described, and their requirements are discussed. Obligations which need to be filled for post-marketing approval are outlined. As changes to procedures and regulations occur, the module is updated, and therefore, serves as a good reference tool allowing not only experienced but new users to stay updated with the broader picture of the environment of regulatory affairs.
