Experience with the organisation of pharmacovigi-lance training courses at the WHO Uppsala Monitoring Centre (UMC) has shown that a number of basic components of a training programme can be put forward (see Table 41.2). Training programmes can be organised by academic units in a country, specialised in clinical pharmacology, clinical pharmacy or pharmacoepi-demiology. As a rule, collaboration is recommended with the pharmacovigilance agency in the country and with additional disciplines in order to provide appropriate teaching in, for example, the clinical manifestations and pathology of ADRs, the practicalities of spontaneous reporting and drug regulation. Some examples of institutes regularly organising such programmes in Europe are given in Table 41.3. In addition, several commercial educational organisations in countries around the world organise more or less comprehensive training programmes, incidentally or regularly. At the international level, the UMC organises every other

Table 41.2. Outline of a pharmacovigilance course.

• Needs for and aims of pharmacovigilance

• Clinical medicine, pathology, pharmacology and epidemiology of adverse drug reactions

- Drug interactions

- Drugs in pregnancy

- Drugs and lactation

• Practice of spontaneous reporting

- Organisation and maintenance of a pharmacovigilance centre

- IT aspects of spontaneous reporting

- Case report assessment, terminologies, coding, standardised causality assessment

- Principles of signal detection and follow-up

- International collaboration; the WHO-UMC International Pharmacovigilance Programme

• Drug legislation and regulation; requirements and guidelines. International harmonisation and standardisation

• Principles of pharmacoepidemiology and the practice of other methods (e.g. prescription-event monitoring, case-control surveillance, database mining, nested case-control studies, comparative follow-up studies)

- Vaccine vigilance

- Pharmaceutical defects; counterfeit

- Drug dependence

• Literature sources

• Benefit-risk assessment

• Communications

- Writing a report or a publication year a training course for a mixed audience, coming from governmental agencies, academia and pharmaceutical companies. In addition, the UMC is committed to provide teaching material to national or regional teaching initiatives regarding, in particular, the practice of spontaneous reporting, the organisation of a pharmacovigilance centre, information technology, terminologies, harmonisation and standardisation, signal detection methodology and communications. An example is the recently published Guidelines for Setting Up and Running a Pharmacovigilance Centre (also in Spanish and available on the Internet: As the global organisation of professionals working in pharmacovigilance, the International Society of

Table 41.3. Examples of institutes offering recurrent training in pharmacovigilance.

The Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring)

Stora Torget 3 S-753 20 Uppsala Sweden tel: +46-18-656060

fax: +46-18-656080

e-mail: [email protected]

London School of Hygiene and Tropical Medicine

50 Bedford Square London WC1B 3DP UK

tel: +44-20-72994648 fax: +44-20-73230638 e-mail: [email protected]

University of Hertfordshire

Hatfield Campus College Lane, Hatfield Herts, AL10 9AB UK

tel: +44-1707 284800

fax: +44-1707 284870

e-mail: [email protected]

University of Wales

Department of Pharmacology, Therapeutics & Toxicology, UWCM, Heath Park, Cardiff CF14 4XN, UK

tel: +44-29 20 747747 fax: +44-29 20 748316


Oudedijk 9B 3062 AB Rotterdam The Netherlands tel: +31 10 244 7399 fax: +31 10 244 7319

Pharmacovigilance (ISOP: is a platform for the further development of pharmacovigilance, as a science and as a profession. ISOP is preparing programmes for the stimulation of pharmacovigi-lance teaching activities and for the development of quality standards and "good practices''. Furthermore, related organisations, such as the International Society of Pharmacoepidemiology (ISPE) and the Drug Information Association (DIA) are increasing their contributions to teaching pharma-covigilance.

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