(1997; 248 pages) [French]
1.10 Technical competence
A small licensing authority will rarely, if ever, undertake comprehensive independent assessments of the safety and efficacy of individual products. The administrative and technical responsibilities that fall within its ambit are essentially of a pharmaceutical nature and they are directed primarily to quality assurance. The professional staff must include members with a thorough understanding and practical experience of the different facets of this work.
The responsible officer is accountable for the professional validation and assessment of licence applications and for the administrative aspects of licensing and, as such, should be involved in determining priorities and developing a timetable for implementation of controls. These activities require administrative and clerical support and premises sufficient to handle the large volume of documentation involved with appropriate confidentiality. Efficiency of operation is enhanced when the required information can be retrieved rapidly from a computerized data base.