COMMENT: Companies facing on-the-spot rule changes during EU routine audits
This article was originally published in Clinica
Executive Summary
Companies are now being caught out because aspects of the European Commission Recommendation 2013/473/EU are being enforced by notified bodies during routine audits, even though they are not law. Rod Ruston, director of Priory Analysts consultancy, argues that current regulatory intervention has gone too far and is disproportionate to risk