• The DSRU team is at DIA Europe 2018 in Basel!

      Come and see us in the exhibition hall at Booth 112 to find out about our post-authorisation safety studies (PASS), as well as: DSRU Consultancy ECHO – our PV initiative for mental health products Our European network studies …and our wide range of other studies. DSRU Director, Professor Saad Shakir, will be chairing and speaking in […]

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  • DSRU Consultancy: World class science at a not-for-profit price

    Saad Shakir writes: DSRU Consultancy provides consultancy and advice on matters related to Pharmacovigilance, Pharmacoepidemiology, Risk Management and Risk Minimisation. The DSRU consultants are a team of epidemiologists, physicians, biomedical scientists, IT and data management professionals, who provide the consultancy work individually or as a team. We advise all kinds of companies from the some […]

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  • Blog: Measuring the Impact of Pharmacovigilance 

    Saad Shakir writes: Huge efforts and resources have been allocated to Pharmacovigilance around the world, with enormous progress in the last two decades. Signal Detection, Risk Management and Risk Minimisation are only a few examples of fairly recent developments.  The effects of these and other developments in Pharmacovigilance are real and there are metrics that measure […]

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  • What are the main objectives of PASS studies for Risk Management?

    In this short blog and video, Saad Shakir outlines the main objectives for PASS studies and describes the characteristics of those who are able to conduct such studies: The objectives of Risk Management Studies are essentially to reduce the uncertainties related to the limitations of pre-marketing data and examine the effects of the different characteristics […]

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  • Designing studies for risk management plans that are acceptable to European regulators

    Saad Shakir addresses the challenges of proposing post-authorisation safety (PAS) studies for risk management that would be approved by regulators: Designing and proposing studies for risk management plans (RMPs) requires more than knowledge about the relevant GVP modules and the template.The process needs strategic thinking that requires understanding of: • The pre-marketing data for the […]

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