Onorach’s new suite of eLearning courses includes a range of ‘Essentials’ modules aimed at providing new entrants into the clinical/pharmaceutical industry with a solid foundation of knowledge and understanding.
One of the most popular Essentials courses is “ESS01 – Essentials of EU and US Regulatory Affairs for Human Medicinal Products”. This is a foundation-level module providing an 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.
All staff in the pharmaceutical and biotechnology industries 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. It will also be of benefit to healthcare professionals who contribute to the development of medicinal products.
Because all Onorach eLearning courses are accredited by the Royal College of Physicians Faculty of Pharmaceutical Medicine, successful completion of the module is worth 3 CPD points.
To learn more about this and the other Essentials modules, visit:
Remember, all BioDundee members get a 10% discount on all courses by using code BIODUNDEE10.