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.
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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 [...]
The number of audits and inspections is continuing to increase as all companies implement partner audit programmes and more regulatory authorities initiate inspection programmes. As these activities become increasingly time consuming and complex, it is vital that those involved in the management of the audit or inspection have an understanding of what is required and why. The course will provide you with an overview of the key feature of audits and inspections and discuss what makes a successfully run audit/inspection regardless of the findings. You will obtain practical information and advice on provider audit, the keys to preparing for and effectively managing [...]
Considering a career change? We are running a new one-day course aimed at those looking to move into pharmacovigilance. The 'Thinking of a career in drug safety?' course, taking place on 27 March, is designed to introduce you to the importance of drug safety, how this affects patients, compliance and what it is like to work in a patient safety department. Come along to learn and to talk to our engaging pharma industry speakers. For further details see: www.dsru.org/service/career-in-drug-safety Book now for only £125 + VAT!
Our 4th European Conference on Monitoring the Effectiveness of Risk Minimisation is underway in London. The programme sets the scene, covering methods to determine the effectiveness of risk minimisation measures, followed by more detailed case studies on a retinoid pregnancy prevention plan, risk minimisation for opiates, CAR-T products and much more. Ahead of the main conference, an interactive workshop day was held yesterday to bring risk minimisation newcomers up to speed. #EuroRiskMinConf
The DSRU team is displaying 13 posters at the International Society of Pharmacovigilance Annual Meeting in Geneva in November 2018. The posters represent the breadth of our research, covering DOAC bleeding, flu vaccine ESS, impact of pharmacovigilance interventions on public health, our biosimilar pharmacy study, multi-level modelling and more. Abstracts are listed in full here: https://www.dsru.org/service/isop-november-2018-geneva/
DSRU support to small and medium companies on information, analysis and studies on Observational and Real World Data Large pharmaceutical companies allocate resources to observational and real world data and use these sources at all stages of drug development. Smaller pharmaceutical companies may not be able to do the same. However, they do not need to be left out. The DSRU has a highly experienced team of epidemiologists, physicians and medical research scientists who can support smaller companies to obtain such data, analyse it or conduct formal studies if needed. This can be done on a regular or ad hoc basis. [...]