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The Importance of QMS and Vendor Oversight for Non-EU Sponsors Under The CTR

Good clinical practice is well-entrenched in global biopharmaceutical companies, and almost every sponsor company adheres to the Declaration of Helsinki with regards to following ethical principles in their medical research. For US companies, the standards established by the Food and Drug Administration (FDA) are very much in line with what is required in the European […]

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Independent Oversight: Why It’s a Risk to Have Your CRO as Your Legal Representative

In theory, there is no reason and nothing in the Clinical Trial Regulation (CTR) that prevents a contract research organisation (CRO) being named as the EU Legal Representative by a Sponsor. However, it does beg the question as to whether there would be a conflict of interest, since what it means is the sponsor is […]

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Brexit Poses Challenges for Medical Devices Companies as UK Goes Its Own Way

While it has been nearly two years since the UK withdrew from the European Union, much still remains uncertain about the direction that the Medicines and Healthcare product Regulatory Agency (MHRA) will take with its requirements. Will change happen, and if so when? It’s a bit of a baptism by fire with the regulators only […]