ARTICLE | Regulation
Measuring regulatory outcomes
How EMA wants to use real-world data to study the health impact of safety decisions
November 18, 2017 2:29 AM UTC
EMA wants to increase the use of real-world evidence and digital health to better understand the impact of pharmacovigilance decisions on patient outcomes.
Pharmacovigilance decisions fall along a broad continuum, from small changes such as reducing the size of a packet of pills or adding a drug-drug interaction to a drug label, to larger decisions such as restricting an indication or withdrawing a drug from the market. ...
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