Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022

The European Medicines Agency’s (EMA) management board has agreed to make the International Organisation for Standardisation’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse drug reaction (ADR) reporting to EudraVigilance. Read more “Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022”

An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data

The Clinical Trial and Imaging Subgroup of the European Medicines Agency (EMA) has released a report on the issues associated with the combination of data from different clinical trials into large datasets. Read more “An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data”