• 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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  • DSRU attends the RCGP Annual Conference in Harrogate

    A DSRU team attended the Annual Conference of the Royal College of General Practitioners (RCGP) in Harrogate on 6th – 8th October 2016. The conference welcomes over 1,600 primary care professionals each year and the theme of this year’s conference was “Energising Primary Care”. DSRU medics, Dr Miranda Davies, Dr. Helen Carr and Dr Sandeep […]

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  • Pharmacovigilance Science in the UK and Europe in the years to come

    Saad Shakir 19th July 2016 The UK has been a major player in medicines regulations in the EU since the establishment of the CPMP in 1975.  This contribution increased immensely after the single market was established and the EMEA became operational in 1995. Medicines Regulation in the UK is regulated by the Medicines Act 1968 […]

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