This consultation document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice).
It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action.
Google's DeepMind has moved on from playing Go to more serious matters - attempting to solve some of the world's biggest health problems.
Projects include a tie-up with London Moorfields eye hospital, which will see it using one million eye scans to train its artificial intelligence system to diagnose potential sight issues, and development of an app to help doctors spot kidney disease.
Google's entry on to the healthcare scene has been welcomed by some, notably doctors who are desperate to apply some cutting-edge technology to antiquated NHS systems.
But less so by privacy groups and some patients, who have been surprised and concerned that their data - in some cases not anonymised - can be shared with the tech giant's AI division.
New research suggests that if a medical device hits the market in Europe before it is approved by U.S. regulators, it may undergo less rigorous screening before it is allowed to be used on Americans, and may be more likely to turn out to carry dangerous risks.
In a study published in the medical journal The BMJ, researchers from Harvard and King’s College London found that medical devices were twice as likely to be the subject of a recall if they were approved in the European Union before being approved in the United States.
Researchers looked at the difference between how high profile medical devices first approved in the EU performed in the U.S., comparing the devices to those that were approved in the U.S. first.
On the Andrew Marr Show, Iain Duncan Smith was shown a Vote Leave poster saying: "Let's give our NHS the £350m the EU takes every week," but he denied that promise had been made and said instead that the NHS would receive "the lion's share" of money that would no longer be spent on the EU.
Reality Check on the ‘OUT’ campaign claim: “We send £350m a week to Brussels, which could be spent on the NHS instead”.
One of the most controversial claims of the campaign was that the UK sends £350m a week (or £50m a day) to Brussels, which could be spent on the NHS instead.
Two documents released in the last few days reveal both the severity of the NHS’s financial crisis and why it cannot find a way out.
In a briefing prepared for Sarah Wollaston’s health select committee, NHS England revealed more of the detail behind the £22bn of efficiency savings the health service is supposed to make by 2020-21 to tackle the growing gap between funding and demand.
It said that around £7bn of this will be achieved nationally, such as through pay restraint, leaving £15bn to be found locally. Out of this, £9bn is supposed to come from providers. The Five Year Forward View spelt out the enormity of this task, with providers needing to improve their efficiency by 2% every year – impressive compared with the NHS’s own history, the rest of the UK economy and other countries’ health systems.