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 [...]
About dsruThis author has not yet filled in any details.
So far dsru has created 94 blog entries.
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 [...]
This week we launch the International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance. Experts from over 20 organisations in the pharma industry and academia will attend Friday’s inaugural meeting in London in order to examine aspects of signal detection and signal management. Signal Detection and Management are key steps in the pharmacovigilance process. While the CIOMS Working Group Report on Signal Detection was published in 2010, a lot has happened in this field since then. Thus we are bringing together a group of international experts to examine the science, define the [...]
The DSRU is highly unusual in its capability to conduct PASS studies in hospitals or specialist care. These studies follow our Specialist Cohort Event Monitoring (SCEM) methodology, which we created to address the need to provide safety studies in secondary care, specifically for patients who receive initial or all drug treatment in hospitals or hospital outpatient clinics. […]
Conducting post-authorisation studies in more than one country has several advantages: Local investigators will have a good understanding of the healthcare system in their country. Increases the sample size Such studies satisfy the regulatory requirement to conduct PASS or risk minimisation studies in several EU states Provides assurance that risk management and risk minimisation are working in a number of member states The DSRU conducts European network studies across a number of countries. We bring together a number of partner organisations, write the master protocol for the observational study and act as both a partner and network co-ordinator. The study is [...]