The DSRU’s Second Conference on Big Data for Pharmacovigilance has been a great success. Delegates from regulatory bodies, the pharmaceutical industry and academia have heard presentations from high calibre speakers, examining the challenges and opportunities for use of big data sources for the benefit of pharmacovigilance. Gianluca Trifirò from the University of Messina set the scene with an overview of the current status of big data in pharmacovigilance, including developments since our first Conference on Big Data for Pharmacovigilance in 2018. Niklas Noren from the Uppsala Monitoring Centre detailed some lessons learned in developing and deploying machine learning for pharmacovigilance, including [...]
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The DSRU team is attending the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Philadelphia. Come and meet our team at booth 204, where you can find out about our hospital PASS studies, our CPRD studies and DSRU Consulting. Find out about our research from our posters: Monday 26th August Characterisation of Drug Interaction Related Signals Leading to EU Regulatory Action and a Methodological Review of Novel Drug Interaction Signal Detection Methods in the Post-Marketing Setting D Roy, L Hazell, V Osborne, S Shakir Impact Analyses of European Pharmacovigilance Interventions on Public Health Burden S Lane, E Lynn, J [...]
Our second conference on Big Data for Pharmacovigilance takes place in September in London. We have an impressive line-up of speakers who will examine the use of Big Data from many perspectives. Highlights include: John Rigg, IQVIA: Realising the full potential of artificial intelligence in big populations Andrew Bate, Pfizer: Routine and emerging Big Data Strategies for Real World Evidence generation Andrew Roddam, GSK: Linking genetic information with clinical data Vassilis Koutkias, Centre for Research & Technology Hellas: OpenPVSignal, a tool for electronic exploration of signal reports Eva-Lisa Meldau, UMC: De-identification: use of natural language processing to remove patient identifiers from [...]
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 [...]
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 [...]