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Pharmacovigilance and adverse event reporting: Five keys for establishing worldwide best practice

Pharmacovigilance, an arm of patient care with a charter to make the best use of medicines and data for the treatment or prevention of disease, is taking on growing importance in global public health.

Pharmacovigilance, an arm of patient care with a charter to make the best use of medicines and data for the treatment or prevention of disease, is taking on growing importance in global public health. Pharmacovigilance is a multi- and cross-area discipline that deals with incidence and frequency of adverse events of pharmaceuticals and medical devices worldwide. The reporting of adverse events is critical to the creation of a valid pharmacovigilance program that can identify adverse events before they have an impact on public health.

However, language can be a barrier in the reporting process. In many instances, adverse events and databases are reported in the local language. As a first step, adverse effect reports (AERs) must be translated from the local language to English, with particular care being taken to ensure that patient confidentiality is not breached at any point in the process. Eventually, these reports, combined with additional documentation, are translated into a number of multiple languages to accommodate the requirements of various countries.

Click here to download the free whitepaper ‘Pharmacovigilance: Five keys to language transparency and optimised reporting’ authored by Jan Lessem, M.D., Ph.D.

19th September 2013

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Merrill Brink International

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