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Professor Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE MRCGP qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK and then in the international pharmaceutical industry.
He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine and was elected recently as a Fellow of the International Society of Pharmacoepidemiology. He is a Member of the Royal College of General Practitioners in the UK and continues to practice clinical medicine part-time.
He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial boards of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.
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| Workshop, Monday, 3 July 2006, Oxford University |
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Practical Strategies for Risk Characterisation, Assessment and Management of Medicinal Products
Led by Professor Saad Shakir, Director, Drug Safety Research Unit, UK
No effective medicine is without risk. Most of these risks are known (though not always fully defined) when a product is launched; however, some of the risks are unknown and are discovered during clinical use.
Effective use of medicines requires balancing the benefits and risks. Obviously, risks which are incompletely defined at the time of the launch need to be better characterised and quantified. This requires conducting appropriate studies (observational and experimental).
All the information about the risk/benefit balance is of no benefit to patients unless it results in practical actions at prescriber and patient levels to optimise the risk/benefit balance. In the last few years immense interest from regulatory authorities, the pharmaceutical industry and academia has focused on improving the risk/benefit balance. Various strategies have been adopted to optimise the risk/benefit of these medicines.
This workshop will provide awareness of the methods to characterise risk, assess risk/benefit balance and implement practical strategies for risk management. Case studies will be used.
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