It has, since 2012, been a well-established fact that pharmaceutical companies which have medicinal products or are conducting clinical trials in the European Union (EU) will have to adhere to the ISO standards mandated in EU Regulation 520/2012. With the aim of improving overall pharmacovigilance signal detection and oversight, the European Medicines Agency (EMA) will rely on these standards (11615, 11616, 11238, 11239 & 11240) to achieve this goal. Niels Grønning and Rune Ringsholm Bergendorff at NNIT give us an insight into the data volume of an ISO IDMP submission.
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