EMA Lays Out Plans For Routine Use Of Real-World Evidence

EU Draft Artificial Intelligence Guideline Slated For November 2022

03 Sep 2021

A panel of regulators overseeing the implementation of several big data projects within the EU medicines network has given details of real-world evidence integration pilots to be undertaken next year by various European Medicines Agency scientific committees.

Futuristic programming code and big data connections and network patterns. 3D illustration. — Regulators will increasingly use insights derived from big data to assess the benefit-risk of medicines • Source: Alamy

An updated workplan drawn up by EU regulators to incorporate the use of big data in regulatory decision-making shows good progress is being made to deliver several ambitious projects that were first identified in 2020.

The projects were developed by the Big Data Steering Group (BDSG) that advises the European Medicines Agency and the EU’s...