The London School of Hygiene and Tropical Medicine (LSHTM) has been running a course in pharmacoepidemiology and pharmacovigilence for the last five years. The course was first planned in response to several requests received for some specialised training from people working in pharmacoepidemiology in the United Kingdom.
LSHTM was already well established as one of the foremost teaching institutions for epidemiology, and there were several staff actively engaged on research work around drug safety. First thoughts were to set up a one-year's masters programme in the subject, but early research on likely consumer demand indicated that few people would be able to take the time for such a course because they and their employers would be unwilling for them to the such a long break from the workplace. A shorter course was therefore designed which was nevertheless rigorous, with a requirement to pass a written examination and to submit a student project on an assigned topic that required an understanding of the complexity of safety decisions. There are three teaching blocks, one of four days and two of three days. Each student is assigned an academic tutor to advise on the preparation of the 3000 word student project.
Early on in the course the wide range of people who registered was surprising. It was expected that the constituencies for the course would be people working in pharmacovigilence departments in industry, people working for regulatory authorities, and a few people working in pharmacy policy in health authorities. The first two groups registered in abundance, but each year the course has been enriched by the presence of other interests that have ranged from a medical journalist to an academic studying the safety of alternative therapies. An increasing number of participants come from outside the United Kingdom, while less than half of the people registering for the course are medically qualified.
The aim is to give a wide view of the issues surrounding drug safety, so that all students understand the wider context. In keeping with the educational philosophy of the LSHTM there is a strong emphasis on student participation at all stages, so that formal lectures are interspersed with a variety of coursework sessions and workshops. To allow teachers to give individual attention to students, course numbers each year are strictly limited. The course includes a considerable amount of epidemiological and statistical methods, together with an in-depth review of the regulatory issues and the problems that are faced in industry. Students are encouraged to develop critical skills for appraising the nature and value of the evidence they are faced with.
This course is generously supported by many other organisations whose staff give their teaching time for free. In particular, many of the teachers are drawn from the Medicines Control Agency, but heartfelt thanks are also due to the many industry personnel, independent consultants and fellow academics who give their time every year to ensure that students are exposed to the widest possible range of perspectives. It is hoped that this course makes a valuable contribution to the conduct of pharmacovigilence activity throughout Europe.
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