Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

Jürgen Beckmann, Ulrich Hagemann, Priya Bahri, Andrew Bate, Ian Boyd, Gerald Pan, Brian Edwards, I. Edwards, Kenneth Hartigan-Go, Marie Lindquist, John MCEWEN, Yola Moride, Sten Olsson, Shanthi Pal, Rachida Soulaymani-Bencheikh, Marco Tuccori, Claudia Vaca, Ian Wong

Research output: Contribution to journalEditorialpeer-review

38 Citations (Scopus)


The importance of pharmacovigilance (PV) for safe medicines and their safe use has increasingly been recognized during the last few years [1]. PV has been subject of intense research and regulation. In particular, it has earned more and more importance and attention in low-resource countries. This is largely due to the globalisation of trade and the availability of new, highly effective but potentially harmful chemical medicinal products in those parts of the world where traditional treatments, in particular herbal or other complementary remedies, used to prevail. A plethora of publications, guidelines and information about newly observed or further investigated adverse drug reactions (ADRs) from all over the world creates a growing burden for people working with medicines or patients to keep abreast of this development. Largely due to the global availability of information through the Internet, patients are nowadays more and more critical and often concerned about, or even frightened of, potential ADRs of their medicines. This poses an additional demand on the up-todate capacities of their doctors and other healthcare professionals (HCPs). A particular challenge is the multidisciplinary character of PV which requires know-how in topics as different as molecular mechanisms of ADRs, clinical medicine, pharmacoepidemiology, information technology, pharmaceutical manufacturing, legal aspects, public health situations on various levels, and traditions in different regions of the world. Also, theoretical knowledge needs supplementing with experience and practical skills
Original languageEnglish
Pages (from-to)743-759
Number of pages17
JournalDrug Safety
Issue number10
Publication statusPublished - Oct 2014


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