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Report study results or face a big stick: the pros of regulatory penalties

Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational. Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to […]

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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 […]

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Getting Ready for the Clinical Trial Regulation

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials.  It is however important to keep a finger on the pulse of the […]

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Data protection to take centre stage in 2021

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]

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Why Transparency in reporting negative results is key for public trust

A recent perspective piece published in the New England Journal of Medicine highlights an issue that I have long felt reflects poorly on the industry, and that is public mistrust in ’Big Pharma’. This issue has come to the fore with the race to bring a Covid-19 vaccine to market. While the authors talk about […]

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Balancing risk and reward: The cost of providing legal representative support

When regulations change there are always a few aspects where the careful reader finds themselves asking “did they really mean that?”. In that vein there is a somewhat ominous clause in the new Clinical Trial Regulation, at least from the point of view of the legal representative. Article 74 of the regulation states: “Such legal […]

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Quis custodiet ipsos custodes: Who will hold the sponsors to account?

The long-awaited new Clinical Trials Regulation looks set to be introduced in 2020. Initially adopted in 2014 and due to go into force soon afterwards, it was held up by technical difficulties with the database, which is necessary to underpin the new environment. The latest testing suggests these problems have been resolved. The new regulation […]

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Silver Linings: How Regulatory Learnings from the Covid-19 Pandemic Could Bring Future Improvements to Research

I’m a huge believer that even in the very worst of circumstances, there is always a silver lining (or two) to be found. We  have already seen some of these playing out during this pandemic in the many ways people are coming together to spread hope and goodwill between and across communities. One positive that […]