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Interview: June Raine and the rise of pharmacovigilance and risk management

This article was originally published in SRA

Executive Summary

Barely three years old, the Pharmacovigilance Risk Assessment Committee is the European Medicine Agency's new kid on the block. The PRAC, according to its chair Dr June Raine, is a "clear voice for public health" that will only get louder as companies and regulators increasingly focus on providing earlier access to medicines and demand for real life data grows. Dr Raine talks to Scrip Regulatory Affairs about the PRAC's role in risk management, adaptive pathways, data gathering and the voice of the patient.