How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002: V. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM: C. Retaining Staff

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

	ACKNOWLEDGEMENTS
	I. INTRODUCTION
		A. Background
		B. Purpose of Guide
		C. Benefits of Computer-Assisted Drug Registration
		D. Key Concepts
		E. Summary of Implementation Process Steps
	II. PRE-REQUISITES FOR COMPUTER-ASSISTED DRUG REGISTRATION
		A. Legislation and Regulations
		B. Human Resources
		C. Adequate Financing Mechanisms
		D. Hardware and Software
	III. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION
		A. Planning the Process
		B. Review and Update Procedures
		C. Review and Update Forms and Certificates
	IV. COMPUTERIZING DRUG REGISTRATION
		A. Data to Be Computerized
		B. Preparing Data
		C. Options for Entering Data into the System
		D. Using the Computer in the Drug Registration Process
		E. Train Staff
		F. Ensure Computer System Support
	V. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM
		A. Written Procedures
		B. Checking Quality of Data
		C. Retaining Staff
		D. Political Support
		E. Maximize Existing Resources
	ANNEXES
		Annex 1: List of Acronyms
		Annex 2: The Drug Registration Process
		Annex 3: Specific Aspects of Drug Registration Legislation
		Annex 4: Minimum Requirements for a Drug Regulatory Authority
		Annex 5: Glossary
		Annex 6: Sample Data Entry Form
		Annex 7: Further Reading

C. Retaining Staff

The introduction of computer-assisted drug registration is a major undertaking and investment. The investment also involves training of staff. If staff leave the DRA, most of the effort put into their training is lost. Therefore, DRAs should try to ensure that critical staff are not lost to the private sector or other agencies. Some ways to retain staff may include opportunities for training, fair salaries, and establishing an appropriate level of status for the positions.

Several countries in Africa and Latin America have been successful in retaining qualified staff by providing incentives, such as training opportunities, and by ensuring that salaries are maintained at a level competitive with the private sector. This has been made possible by creating a regulatory authority that has a separate administrative set up, while remaining under the control of the Ministry of Health.