WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Close this folderAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Open this folder and view contents1. General remarks
Open this folder and view contents2. Training programme for inspection
Open this folder and view contents3. Training programme on examination
View the documentReferences
View the documentWorld Health Assembly resolutions
View the documentAppendix 1 The practical issues of organizing and implementing the programme
View the documentAppendix 2 Thin-layer chromatography and its application
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Appendix 1 The practical issues of organizing and implementing the programme

Getting started

1. Establish a core group for organizing the training programmes

• Organize the core group for planning and implementing the education programme. The group may be organized by health authorities, or by nongovernmental organizations or joint enterprises.

 

• Establish roles and responsibilities for all participants in planning and implementation.

 

2. Develop the profile of what is required and estimate the output of the programme

• Construct the profile of the required system of national or local drug distribution in terms of the characteristics of both professionals and the general public.

 

• Collect data regarding the target professionals.

• Assess the overall performance of the target professionals.

• Identify the extent of the responsibility of the target professionals in combating counterfeit pharmaceuticals.

• Identify what the professionals need to improve their performance in combating counterfeit pharmaceuticals, and prioritize according to the available resources.

• Identify the "end products" to be achieved by the training programme.

 

3. Plan the curriculum according to the need

• Develop a survey of the needs.
• Identify sources of data and other resources.
• Prepare a plan (who, where, when) for collecting data.
• Collate information.

 

4. Assess the facilities and staff available

• Assess the available teaching staff, equipment and facilities in institutions for training.

 

• Determine whether additional staff and equipment will be needed to meet the objectives and provide the curriculum as planned.

 

5. Work with other concerned parties

• Identify institutions, groups and persons in the community with whom to collaborate.

 

• Share information with these institutions, groups and persons in order to encourage collaboration in the programme.

• If there are not enough resources available in the target area, find resources outside the area.

 

6. Select the target groups

• Identify the target professionals and select the core groups for whom the programmes will be most effective.

 

• Ensure that the distribution of participants in the training programme is balanced in terms of disciplines and regions.

 

Initiating implementation

1. Secure financial support

• Investigate potential and existing internal and external sources of financial support for the programme.

 

2. Gather materials for a curriculum

Contact institutions, agencies and other organizations with experience and expertise in the pharmaceutical training fields, including WHO and its collaborating centres.

 

3. Make arrangements for the trainees

• Arrange accommodation and travel for the trainees, if necessary.

 

4. Recruit teaching staff

• Contact and recruit suitable teaching staff.
• Arrange their accommodation and travel, if necessary.

 

5. Establish a positive image for the goal of the programme

• Identify core trainees who understand the meaning of the programme and support it.
• Obtain early support by key persons.

 

6. Deal with barriers

Attempt to overcome resistance to the programmes (e.g. reluctance to take up the issue of counterfeit pharmaceuticals).

 

Selected further reading

Developing protocols for change in medical education. Geneva, World Health Organization, 1995 (unpublished document WHO/HRH/95.5; available on request from Department of Health Systems, WHO, 1211 Geneva 27, Switzerland).

Guilbert JJ. Educational handbook for health personnel, 6th ed. Geneva, World Health Organization, 1987 (revised and updated 1998) (WHO Offset. Publication No. 35).

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