This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. When changes to regulations and procedures occur, the module is updated and hence serves as a handy reference tool allowing new as well as experienced users to keep up to date with the broader picture of the regulatory affairs environment.


Who will benefit from this module?
All staff in the pharmaceutical industry who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool.