Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuIntroduction
Fermer ce répertoire1. National drug regulation
Fermer ce répertoireGuiding principles for small national drug regulatory authorities1,2
Fermer ce répertoire1. General considerations
Afficher le document1.1 The scope of drug control
Afficher le document1.2 Basic responsibilities
Afficher le document1.3 Licensing functions
Afficher le document1.4 Product licences
Afficher le document1.5 Manufacturers’ and distributors’ licences
Afficher le document1.6 New drug assessments
Afficher le document1.7 Authorization of clinical trials
Afficher le document1.8 Terms of reference of the regulatory authority
Afficher le document1.9 Powers of enforcement
Afficher le document1.10 Technical competence
Afficher le document1.11 Advisory bodies
Afficher le document1.12 Independence of operation
Ouvrir ce répertoire et afficher son contenu2. Administrative aspects of the licensing process
Ouvrir ce répertoire et afficher son contenu3. Technical aspects of the licensing process
Ouvrir ce répertoire et afficher son contenu2. Product assessment and registration
Ouvrir ce répertoire et afficher son contenu3. Distribution
Ouvrir ce répertoire et afficher son contenu4. The international pharmacopoeia and related activities
Ouvrir ce répertoire et afficher son contenu5. Basic tests
Ouvrir ce répertoire et afficher son contenu6. Laboratory services
Ouvrir ce répertoire et afficher son contenu7. International trade in pharmaceuticals
Ouvrir ce répertoire et afficher son contenu8. Counterfeit products
Ouvrir ce répertoire et afficher son contenu9. Training
Afficher le documentSelected WHO publications of related interest
Afficher le documentBack cover
 
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.

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Dernière mise à jour: le 3 mai 2013