Practical Experience in Teaching Pharmacovigilance

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Chapter: Pharmacovigilance: Practical Experience in Teaching Pharmacovigilance

A short course in Pharmacoepidemiology and Pharmacovigilance at the London School of Hygiene and Tropical Medicine was started in 1997, and the tenth course has just begun in 2006.


A short course in Pharmacoepidemiology and Phar-macovigilance at the London School of Hygiene and Tropical Medicine was started in 1997, and the tenth course has just begun in 2006.

There are only a limited number of university-based examined courses in Europe in which pharmacovig-ilance is a major component. Another example is a flexible Masters course in Pharmacovigilance taught at the UK University of Hertfordshire, which can have components used to have diploma or certificate courses. This course largely uses external teachers.

The London School of Hygiene & Tropical Medicine (LSHTM) is Britain’s national school of public health and a leading postgraduate institution in Europe for public health and tropical medicine. Part of the University of London, the London School is an internationally recognized centre of excellence in public health, international health and tropical medicine with a remarkable depth and breadth of expertise.

The LSHTM course is part-time and comprises 190 h (approximately 1 day per week) that are spent as follows: 70 h formal teaching and contact time, 70 h self-directed study and 50 h project work. Formal teaching takes place as three sessions of 3 or 4 days in a week (total 11 days) spread over 5 months. Exami-nations and a project are used to assess students, and there is a high, but not 100%, pass rate.

While LSHTM has a sizable active group of researchers studying adverse effects of medicines (over 30 publications in the last 5 years), the course uses external teachers also. Outside experts, particu-larly from regulatory agencies and those with indus-try experience in pharmacovigilance, help teach, and some hold honorary positions in LSHTM. Part of the course covers the historical and legal background of pharmacovigilance and pharmacoepidemiology, phar-macological basis of adverse drug reactions and the application of pharmacoepidemiological princi-ples and methods to practical drug issues.

The experience of both teachers and participants seems to have been generally very positive. Students have come from a wide variety of backgrounds and  European countries, with numbers per year generally being about 10–20. In recent years, an increase in people coming from outside Europe, especially Africa, has been seen.

There is a need for more courses of this type, which give a recognized qualification, targeted at the special problems seen in areas like Africa.

A short ‘commentary’ was published in 2002 (Dunn and Thorogood, 2002) describing the course, though it has developed further since that publication.

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