Saad Shakir has been the Director of the Drug Safety Research Unit (DSRU) in Southampton, UK for more than ten years. He is medically qualified and has been working in pharmacovigilance & pharmacoepidemiology for more than twenty years. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, Fellow of the Faculty of Pharmaceutical Medicine and 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. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines, pharmacoepidemiology and risk management. Saad Shakir has high national and international profiles in pharmacovigilance, pharmacoepidemiology and risk management. He is heavily involved with advising on and conducting studies on risk management of medicines, he has studied and advised on many drug safety issues including product withdrawals and major drug safety hazards. He is an author of more than one hundred publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial boards of the journals of Drug Safety and Pharmacoepidemiology & Drug Safety. He has acted as a chairman and member of Data Safety Management Boards (DSMBs). He is an examiner at the Faculty of Pharmaceutical Medicine in the UK. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees. Saad Shakir is a member of ENCePP (the European Network for Centres with Excellence in Pharmacovigilance and Pharmacoepidemiology). He has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology. Saad Shakir has keen interest in the application of EU regulations in pharmacovigilance, particularly the new EU legislation in this field.