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. […]
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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. [...]
Our 4th European Conference on Monitoring the Effectiveness of Risk Minimisation is coming up on 20-21st November, preceded by a tutorial day on 19th November. While additional risk minimisation methods have now become established, in this year’s conference we will look at new methods for determining whether they actually accomplish what they set out to achieve, as well as risk minimisation methods applicable to the latest generation of medicines. Topics include: Developing REMS and additional risk minimisation measures for the same product (Dr Anne-Ruth van Troostenburg de Bruyn, Gilead) Use of surveys to evaluate the effectiveness of risk minimisation measures: a report on [...]
We are delighted to launch our new website. The homepage has been simplified to allow easy access to our three key areas of expertise: Studies, DSRU Consulting and Training. The Studies section outlines our capabilities in observational studies, including drug utilisation, CPRD, risk minimisation, ECHO for mental health products, MEP for methodological research, event monitoring studies in primary or secondary care (MPEM and SCEM), registries and much more. The DSRU Consulting section outlines the advice we provide to companies both big and small in risk management, pharmacoepidemiology and pharmacovigilance. There is also information on our special consultancy service in pharmacoepidemiology for smaller [...]
The DSRU has a unique method for conducting post-authorisation safety studied (PASS) on medicines prescribed in hospital or specialist care. This SCEM (Specialist Cohort Event Monitoring) methodology allows us to work directly with specialists and health care teams in hospitals in order to recruit patients to the observational study and collect utilisation and safety data. We are now working on our fourth SCEM study. This method is ideal for studying the safety or utilisation of medicines that are initially prescribed in hospital or specialist care and later transferred to primary care. We work closely with specialists in the relevant therapeutic [...]