(1993; 36 pages)
The Committee was informed of various training activities that had been organized or planned since its previous meeting in December 1990 (3). These included several regional and subregional courses on administrative aspects of drug control - and particularly on the drug registration process - organized by the German Foundation for International Development. It was agreed that, while training at international level should be continued, it would be useful if some resources could be provided to meet an important and largely unsatisfied need to support postgraduate courses and continuing education. These would provide an opportunity for topics such as the WHO Certification Scheme and the WHO guidelines on good manufacturing practices to be discussed at the national and local level.
The purpose of training, it was agreed, was not only to increase technical competence, but also to develop awareness of the tasks and responsibilities of regulatory officials, particularly with regard to quality assurance. It was also agreed that a comparable need exists in the manufacturing environment. Indeed, training packages for the authorized person in the manufacturing facility, as defined in the WHO guidelines on good manufacturing practices, are already used in some countries.
A model software package designed to support the drug registration process, developed by WHO with financial support from the German and Italian governments, was considered by the Committee to be of great potential value. This package is available in English, French and Spanish and can easily be translated into other languages. It can also be adapted to meet specific local requirements. Both the software and on-the-spot training are available to national drug regulatory authorities on application to WHO.
The Committee commended the various training activities already being carried out and confirmed the recommendations made in its previous report (3), particularly with regard to the training of laboratory technicians. Looking ahead, it underscored the need for further development of computer software packages to support the various aspects of drug regulation and control.
The need for basic training of regulators remains as high as ever, partly as a consequence of the continuing high turnover of such personnel. The losses of well qualified persons from the regulatory environment might well often be decreased at relatively low cost by the provision of more attractive career structures.
The Committee acknowledged with appreciation the generous and sustained support of training activities by the governments of Germany, Italy and Japan and by the German Foundation for International Development, the International Federation of Pharmaceutical Manufacturers Associations and the WHO Collaborating Centre for Chemical Reference Substances.