How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
(1998; 74 pages)
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Ouvrir ce répertoire et afficher son contenuI. INTRODUCTION
Ouvrir ce répertoire et afficher son contenuII. PRE-REQUISITES FOR COMPUTER-ASSISTED DRUG REGISTRATION
Ouvrir ce répertoire et afficher son contenuIII. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION
Fermer ce répertoireIV. COMPUTERIZING DRUG REGISTRATION
Afficher le documentA. Data to Be Computerized
Afficher le documentB. Preparing Data
Afficher le documentC. Options for Entering Data into the System
Afficher le documentD. Using the Computer in the Drug Registration Process
Afficher le documentE. Train Staff
Afficher le documentF. Ensure Computer System Support
Ouvrir ce répertoire et afficher son contenuV. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM
Ouvrir ce répertoire et afficher son contenuANNEXES
 

IV. COMPUTERIZING DRUG REGISTRATION

KEY POINTS OF THIS CHAPTER

Preparing data for computerization includes completing a data entry form, deciding on a drug classification system, and preparing codes and catalogues for standardized data entry.

If data are usable, they can be entered in the system by: converting old data; stopping new applications and entering the backlog; or entering the backlog gradually while accepting new applications.

If data are unusable, an inventory of the market situation must be made, requiring that companies with products on the market that wish to keep marketing them make this known in writing to the DRA. The other option is that companies submit a full application for marketing authorization based on published documentation and standards.

When computerizing, automation of drug registration work takes place at various steps.

Whatever software system is selected for use at a DRA, staff will need to be trained in how to operate it.

For a computer-assisted drug registration system to function effectively, adequate computer support and maintenance must be available, and the type of support needed differs for a network versus a stand-alone system.

The DRA budget should contain adequate funds for computer system supplies, upgrades, and maintenance.

Once the preliminary activities described above have been completed, the focus shifts to computer-related work. The first issues to be addressed are identifying and preparing data.

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Dernière mise à jour: le 3 mai 2013