Drug development in the Pharmaceutical Industry is a long and complicated process demanding competent employees in all areas of research and development. It is envisaged that the need for such employees will increase considerably in future years.

In an attempt to help bridge the gap between drug development and approval, the Danish Association of the Pharmaceutical Industry (Lif) did in 2002 expand its educational activities and established a formalised regulatory school termed “Medicademy – Regulatory Affairs”. Medicademy offers a course leading to a Diploma in Regulatory Affairs, which will is offered internationally and performed through English.

The education is intended primarily for employees with a minimum of two years’ experience either in the Pharmaceutical Industry or at the Health Authorities. Other participants will be considered on a case-by-case basis.

The course comprises 12 modules each of 2-4 days duration. Lecturers are drawn worldwide from the Pharmaceutical Industry, Health Authorities and Academia and the training is interactive in nature. Each module is concluded with an examination and a certificate issued to successful candidates. A diploma is awarded on successful completion of eight modules.

The course design is flexible and we expect the Medicademy education to become a full master degree in co-operation with the Danish University of Pharmaceutical Sciences, covering the regulatory affairs area, in the first half of 2007.