Description
The Global Pharmaceutical Regulatory Affairs Professional Certification Program offers a foundation-level training. It is the ideal introduction for entrants new to the field of pharmaceutical 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.
The program move on to describe the life-cycle of a drug. The multiple procedures available for approval and assessment of products are described, and their requirements are discussed and described. Obligations which need to be filled for post-marketing approval are outlined.
As changes to procedures and regulations occur, this program is updated, and therefore, serves as a good reference tool allowing not only new users, but also experienced users, to stay updated with the broader picture of the environment of regulatory affairs.
This program includes details of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requirements for obtaining approval for a new drug in the USA (the NDA process) and for obtaining FDA approval for a generic product in the USA (the ANDA); electronic common technological document (CTD); preparing submissions in the common technical document (CTD); orphan drug application in the US and EU; essentials for human medicinal products in US and EU; and registration of monoclonal antibodies.
