In 2017-18, the NHS saved over £200 million by using more biosimilar medicines1. In 2018, NHS England announced plans to increase the uptake of biosimilars with the aim to save up to £300m a year by 20211. Generic versions of small molecule medicines can be considered chemically identical to the original branded version. A biosimilar is, in principle, the biologic equivalent of a generic drug. However because these are large complex molecules, often produced by living cells, a biosimilar is not regarded as identical to the original biologic drug. The manufacturing process of a biosimilar is very complex, so a lot [...]
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Congratulations to our students who graduated from Masters in Pharmacovigilance earlier this month. Students graduating either completed their Postgraduate Certificate, Diploma or Masters in Pharmacovigilance, a collaborative programme run with the University of Portsmouth. Our postgraduate qualifications are designed to to be flexible and are suitable for those in full time employment. For minimal time away from the workplace, the option is available to choose to complete two or four modules per year, depending on other commitments. All assignments can be completed and submitted remotely. Hear from one of our Masters graduates, Dania Shamil, who joined the programme to kick start [...]
The launch teleconference for the International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance took place last week. The key points raised included: The advantages of involving artificial intelligence in signal detection The role of risk-benefit assessment in the lifecycle of signal detection Issues with definitions that need to be resolved: such as what is our definition of a signal? The need to include clinical aspects in signal detection/ the need to always be mindful of how the drug is going to be used The call was attended by 38 of the IWG's 50 signal detection experts from [...]
The International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance is taking shape. The IWG now includes members from nearly 20 pharmaceutical companies, 12 academic institutions and 3 medicines regulators worldwide. A list of objectives and corresponding subgroups for the IWG have been drafted for discussion at the upcoming "roundtable" teleconference. Once agreed, the work of the IWG can begin in earnest. Subgroups will meet remotely to define the science and issues around their given objective and propose ideas and guidance for improvement. See this video for further information on the modus operandi of the IWG. The IWG on [...]
Our 10th Biennial Conference on Signal Detection and Management is now underway. Today we have a packed house for the pre-conference tutorials, with a great panel of inspiring speakers who provide background and introduction to key signal detection concepts, prior to the start of the main conference tomorrow. This year's conference provides detailed presentations on new methodologies from around the world, as well as updates on established methods. Topics include the European Signal Management Pilot, screening for unknown drug-outcome associations, prioritisation of signals, the EHDEN network, the DSRU's International Working Group on Signal Detection and much more. The full programme is [...]
In this week’s PharmaTimes article, Professor Allan Young (Institute of Psychiatry, King’s College London) explains why the unique service offered by ECHO (European Consortium for Observational Studies on Mental Health Products) has such an important role to play in bringing new mental health products to market in Europe. While many new drugs in the mental health sector are first launched in the US, they must undergo post-authorisation safety studies (PASS) and other observational studies in Europe as a condition of approval by the European Medicines Agency (EMA) and other medicines regulators. ECHO is well-placed to conduct these studies, with its pharmacoepidemiological [...]
The DSRU Consultancy has a small flexible team of epidemiologists, clinicians and pharmacists. Watch this short video to find out how DSRU Consultancy provides advice in pharmacoepidemiology, pharmacovigilance, risk minimisation and risk management. We can provide one-off or ongoing advice or we may give advice that leads to provision of a full study service. We also provide a special consultation service to smaller companies. Working with DSRU consultancy may involve these steps: Understanding the safety issue: We develop a full understanding of the safety issue by meeting with you to hear your requirements, finding out about the product and the stage [...]
Here at the DSRU, we are experts at conducting Post-authorisation Safety Studies (PASS) on medicines prescribed in primary, secondary and specialist care. If your company is nearing the point of submission for European marketing authorisation, please get in touch to find out what sets us apart from other providers. We have decades of experience, access to NHS prescribers and data and a unique methodology for European network studies. We think you’ll find our fees are very reasonable too, being a non-profit unit. Impeccable track record Dozens of post-authorisation studies completed In-depth understanding of European Pharmacovigilance regulations Flexible, nimble team of clinicians, [...]
A small team from the DSRU will be at the International Society for Pharmacoepidemiology (ISPE) Mid Year conference in Rome. Come and find us in the exhibition to find out more about the DSRU as a broad pharmacoepidemiology unit. In particular, we'd like to tell you about our PASS studies in hospitals, our European network studies and the epidemiology consulting that we offer to all, especially small companies. We look forward to meeting friends old and new.
What our research on UK drug withdrawals can tell the Independent Medicines and Medical Devices Safety Reviewdsru2019-03-26T13:32:47+00:00
By Dr Elizabeth Lynn, Head of Scientific Development and Education at the Drug Safety Research Unit. Monitoring adverse side effects is our core focus at the Drug Safety Research Unit (DSRU). We are an independent and impartial UK pharmacoepidemiology unit established in 1981 to protect patients from unwanted adverse effects of medicines in clinical use. We recently gave evidence to Baroness Cumberlege as part of the Independent Medicines and Medical Devices Safety Review, which is looking at the safety of the hormone pregnancy test Primodos, surgical mesh, and the anti-epileptic drug, sodium valproate. While we have not studied these three medical [...]