An Introduction to Pharmacovigilance

Chapter 1:       What is pharmacovigilance and how has it developed?       

Chapter 2:       Basic Concepts                                                                    

Chapter 3:       Types and Sources of Data                                                           

Chapter 4:       The process of pharmacovigilance                                             

Chapter 5:       Regulatory aspects of pharmacovigilance                                 

Chapter 6:       International collaborations                                                       

Chapter 7:       Clinical Aspects of pharmacovigilance                          

Chapter 8:       Ethical and social considerations                                              

Chapter 9:       Future Directions

Professor Patrick Waller has the been the Chair of the Independent Scientific Advisory Committee for MHRA database research (ISAC) since 2012and an Honorary Professor at the London School of Hygiene and Tropical Medicine since 2011. He graduated in medicine in Sheffield in 1980 and then trained in clinical pharmacology and epidemiology. Subsequently he worked at the Drug Safety Research Unit in Southampton and the Medicines Control Agency in London. From 1998–2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of the EU Pharmacovigilance Working Party. From 2002–2011 he was an independent consultant in pharmacovigilance and pharmacoepidemiology. 

Associate Professor Mira Harrison–Woolrych has over twenty years experience in pharmacovigilance, pharmacoepidemiology research and medicines regulation in the UK and New Zealand (NZ). She trained in clinical obstetrics and gynaecology and undertook post–graduate molecular biology research at Cambridge University.  As Director of the NZ Intensive Medicines Monitoring Programme for ten years (2003–2013) she led numerous pharmacoepidemiology studies, with many publications in high–ranking journals.  She has recently edited a new textbook Medicines for Women (Springer International 2015).  Dr Harrison–Woolrych is currently an Honorary Research Associate Professor at the Dunedin School of Medicine, University of Otago, NZ and a Medical Advisor for the UK Medicines and Healthcare Products Regulatory Agency (MHRA).  She has served on several government advisory committees and the Executive Committee of the International Society of Pharmacovigilance (ISoP).