DSRU Director, Professor Saad Shakir, attended a three day meeting in Erice in Sicily on “Improving the Detection Analysis and Reporting Harms in Medicines”. The meeting was organised by the Uppsala Monitoring Centre and the Centre for Evidence Based Medicine in Oxford. The areas addressed at the meeting were the problems and proposed solutions for monitoring adverse drug reactions in clinical trials, the problems and proposed solutions for postmarketing pharmacovigilance and the problems and possible solutions for communications of drug safety. Professor Shakir chaired the session and led the discussion on the proposed solutions for postmarketing pharmacovigilance. He said that a [...]
About dsruThis author has not yet filled in any details.
So far dsru has created 94 blog entries.
Our Principal Research Fellow, Vicki Osborne, writes: The opioid crisis in the US is well known and the subject of much debate and media coverage; overdoses involving opioids contributed to over two thirds (67.8%) of overdose deaths in the US in 2017 alone, with 47,600 deaths in total (1,2). Currently, 175 Americans die daily from drug overdoses and the majority of these involve opioids (3). In the UK, we have generally not seen the same levels of use which would cause concern in past years, though it would be complacent to assume that we do not have an issue. According [...]
The DSRU is delighted to be collaborating with the Royal Pharmaceutical Society to deliver two new training days. The courses are designed to introduce the core concepts of the field of drug safety (pharmacovigilance) as well as provide insights into the many career options available. Thinking about a career in the pharmaceutical industry? - Monday 18th November at the Royal Pharmaceutical Society, London Do you know anyone looking to kick start their career in drug safety? This collaborative course is aimed at anyone with an interest in pharmacovigilance and related job roles, no previous experience required. Delegates will be introduced to: [...]
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. The initial consultation is free! Watch this video to find out more or get in touch to discuss your enquiry (with no commitment): Dr Liz Lynn, Head of Scientific & Educational Development, email@example.com
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 [...]
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 [...]