In order to effectively perform its functions staff at the Medicines Regulatory Authorities (MRAs) should have qualifications and experience that are consistent with their responsibilities. Knowledge and scientific skills must be continuously updated to keep pace with drug discovery and development, including the development of new means of formulating, controlling and using well established drugs. It is therefore essential for suitable training and practical experience to be offered regularly to the staff concerned, and that they be encouraged to participate.
WHO have carried out training courses on the assessment of quality, safety and efficacy in the marketing authorization process. This type of courses were carried out in all WHO regions involving participants from over 50 countries. Current training plans include also more general courses on marketing authorization of multisource pharmaceutical products.
For all courses we typically develop a mock application file to be used by participants for their exercises. In addition we provide participants with WHO publications and copies of other materials. Participants also receive copy of all the presentations used the training course.
Announcements about the forthcoming training courses for regulators courses, as well as acceptance requirements for the trainees are regularly published on the WHO/Medicines website.