..read more

Samantha Lane & Saad Shakir As we have said before, pharmacovigilance has moved on from the initial phase of assessing the benefits/risks (B/R) of vaccines and treatments for COVID-19 with the available (limited) data at the time. Pharmacovigilance now has different, more long-term objectives. We are now trying to further our understanding of the nature, risk factors, preventability, frequency, and other characteristics of serious adverse drug reactions (ADRs). More studies and reviews will facilitate better understanding of the ADRs and the B/R balance of the COVID-19 vaccines and treatm ..read more

Professor Saad Shakir During the first 18 months of the pandemic, pharmacovigilance focussed on the immediate urgent tasks for assessing the benefit/risks (B/R) of vaccines and treatments for COVID-19 with the available (limited) data at the time. The world was lucky that COVID-19 vaccines and treatments were mostly effective with few very rare short term adverse drug reactions (ADRs). The main advantages of both vaccines and treatments were that they reduced serious morbidity and mortality for COVID-19 significantly with an acceptable (B/R) balance. Like other communicable diseases COVID-19 ..read more

“The right medicine, at the right dose, at the right time, to the right patient” (GVP, Module XVI) Risk minimisation measures are actions taken to prevent or reduce the occurrence of adverse drug reactions, or to reduce the severity or impact on the patient of adverse reactions that do occur. Routine risk minimisation measures All medicinal products are subject to routine risk minimisation measures, which should be detailed in the Risk Management Plan for the product, in accordance with Good Pharmacovigilance Practice (GVP) Module V. Routine risk minimisation activities relate to the Summary ..read more

After an extended break due to the pandemic, we are delighted that our iconic 11th Biennial Conference on Signal Detection and Signal Management in Pharmacovigilance will take place in London on 28-30th June. This conference is recognised by many as the most important event in the signal detection calendar. The aim of the conference is to provide a showcase for the latest developments in signal detection and signal management, as well as re-establishing the basics. Once again this year we have a high calibre panel of speakers which comprises the finest minds in signal detection from around t ..read more

We are delighted to host this year’s Mid-Year Symposium of the International Society of Pharmacovigilance (ISoP), entitled Beyond Spontaneous Reporting: integrating data from multiple sources to ensure medicines safety. The symposium brings together many high calibre speakers from all over the world, who will present their work in sessions on observational studies, pharmacogenomics, real world data, causality, clinical trials and much more. The programme includes several presentations from our research team. Our Chief Medical Officer, Dr Miranda Davies, will present a case study for Formal B ..read more

The  Drug Safety Research Unit has today launched a new global Institute of Pharmacovigilance Sciences. A team of DSRU physicians, epidemiologists and biomedical scientists will study pressing medicine and vaccine safety issues, and contribute new or improved methods for conducting drug safety research, as part of their work for the Institute. External researchers will also be able to collaborate on projects. The launch marks a major expansion in the DSRU’s expertise and 40-year track record in methodological and pharmacovigilance research. The DSRU is hosting a webinar today with over 2 ..read more

The DSRU Institute of Pharmacovigilance Sciences has been established to build on the DSRU’s  methodological research in pharmacovigilance and pharmacoepidemiology. The launch of the Institute marks a major expansion in the DSRU’s expertise and track record in methodological and pharmacovigilance research, both to improve existing methods and propose new ones. The institute will study important medicine and vaccine safety issues. The work will be conducted both in-house and through collaborations. A small team of DSRU physicians, epidemiologists and biomedical scientists is dedicated to ..read more

Ahead of International Women’s Day on Tuesday 8 March, the UK’s independent Drug Safety Research Unit (DSRU) has announced it’s doubled the size of its research team in the past year, and that 80% of researchers are women, nearly double the UK average. The Covid-19 pandemic created unprecedented demand for DSRU’s drug safety studies in the UK and Europe, monitoring and analysing adverse effects of new drugs and vaccines. These run alongside a substantial portfolio of non-Covid-19 research, including safety studies for UK’s annual flu vaccine, post-operation painkillers, treatments for ulcerat ..read more

Summary: Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination Two years after the start of the COVID-19 pandemic, the scientific response to the SARS-CoV-2 virus is transitioning from the acute to the maintenance phase.  For example, pharmacovigilance has moved from expedited assessments of early signals to working to develop a deeper and broader understanding of the safety of COVID-19 vaccines and medicines. The DSRU is pleased to contribute to the body of pharmacovigilance kn ..read more