Leaders in Risk Management

The Drug Safety Research Unit (DSRU) is an independent academic unit internationally respected for its work in Pharmacovigilance, Pharmacoepidemiology, Risk Management and Training for over 30 years.

In partnership with doctors in England, the DSRU, led by Director Professor Saad Shakir, aims to protect patients in primary and specialist care from unwanted adverse effects of newly marketed medicines using our unique methods of monitoring patients during the lifecycle of medicines.

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DSRU offers a comprehensive range of education and training courses. Find out more or view our complete course calendar.

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11-12 Mar 2015 EU Regulations and Guidelines for Pharma...


New application of methodology published for studies in Secondary Care

NHS hospital sign A paper describing a method for surveillance of products initiated by specialists in secondary care has just been published by the Drug Safety Research Unit (DSRU). The technique, “Specialist Cohort Event Monitoring” (SCEM), is a type of observational post-authorisation safety study ideally suited for Risk Management Plans (RMPs). SCEM has been developed by the DSRU’s expert research team, headed by Director, Professor Saad Shakir. This new application of event-monitoring is one of very few resources in Europe which allow the study of drug safety in the hospital or specialist care setting.

Several SCEM studies are either completed, underway or about to start. All of these contribute to their respective RMPs in the EU. Examples include:
ROSE, a SCEM study to monitor the short term safety and utilisation of Rivaroxaban (XARELTO®) prescribed for medical conditions requiring anticoagulation by specialists in secondary care in England and Wales.
• OASIS, a SCEM study designed to examine the short-term safety and use of quetiapine fumarate in the prolonged-release formulation (Seroquel XL™), in patients with a clinical diagnosis of schizophrenia or mania associated with bipolar disorder.

The publication is freely available here.

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