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A vision for use of real-world evidence in EU medicines regulation

Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025: this is the vision of European regulators as outlined in an article from Peter Arlett, Head of Data Analytics and Methods at EMA, Jesper Kjær, Director of Data Analytics Centre at the […]

CJEU: Courts Cannot Be Prevented From Turning to CJEU By National Supreme Courts

The right of European Union member states to turn to the Court of Justice of the European Union (CJEU) stands above the laws of member states, and so the courts are within their rights to ignore all decisions prohibiting them to seek guidance from the CJEU, the European court ruled on Tuesday.