
Medicademy – Regulatory Affairs is an international educational offer established in 2002 by The Danish Association of the Pharmaceutical Industry (Lif) in collaboration with the Danish University of Pharmaceutical Sciences and the Danish Medicines Agency. A team of Regulatory Affairs Professionals has designed the content of the education.
The Danish Medicines Agency and The Faculty of Pharmaceutical Sciences at the University of Copenhagen are both actively involved in the continuous development of the education through their representation in the Steering Committee, as course leaders and lecturers.
The aim of Medicademy Regulatory Affairs is to provide the employees in the Pharmaceutical Industry and at the Health Authorities with an in depth and up to date knowledge of the most important theoretical and practical aspects of pharmaceutical and biological Regulatory Affairs with specific focus on the European situation but also designated to the USA, Japan and the major markets outside the ICH.
The educational program consists of 13 individual modules and is an offer for further training of employees in the Pharmaceutical Industry and at the Health Authorities, and is aimed at employees with a minimum of 2 years of work experience within the field of Regulatory Affairs.
There are 3 ways students can benefit from the Medicademy education:
- The Medicademy Modules can lead to a Master of Pharmaceutical Regulatory Affairs – MPRA, at the Faculty of Pharmaceutical Sciences at the University of Copenhagen, www.farma.ku.dk/mpra
- The Medicademy Modules can lead to a Diploma in Drug Regulatory Affairs
- The Medicademy Modules can be taken as separate modules in any arbitrary order