Pharmacovigilance (eBook)

Ivor Ralph Edwards is a Professor in Medicine, Senior Advisor, WHO and Uppsala Monitoring Centre.  He was the first Director of the UMC and the inaugural President of the International Society of Pharmacovigilance. He has been Professor of Medicine in Zimbabwe and Director of the National Toxicology Group in New Zealand. Research interests lie in the area of clinical toxicology and pharmacovigilance with a main interest in knowledge finding in drug safety, and  the risk and benefit analysis of drugs.  He has been a consultant to WHO, the UN and UNITAID, and acted in the capacity of expert witness in cases concerning drug and chemical injury in the UK, USA, New Zealand and Sweden. He has published over 300 peer reviewed scientific publications and completed work in 4 books, and serves as a member of the editorial board of Drug Safety and the International Journal of Risk and Safety in Medicine. He is a Fellow of the Colleges of Physicians of London, Edinburgh and Australasia. Marie Lindquist is Director and CEO of the Uppsala Monitoring Centre and heads the Foundation WHO Collaborating Centre for International Drug Monitoring. She has served as Vice President of the International Society of Pharmacovigilance and is a Board Member of the International Society of Pharmacoepidemiology. Her research interests are in clinical epistemiology and ontology with data quality management and analysis of big data, as well as development of problem solving methodology. She has published 57 peer reviewed papers and completed work on 4 books. She has been an expert member of WHO, ISO, CIOMS and ICH working groups, and serves as a member of the editorial board of Drug Safety and the International Journal of Risk and Safety in Medicine. She is a PhD (cum laude) in Medical Science, University of Nijmegen and Honorary Fellow of the Royal College of Physicians (London).

1. How to learn Pharmacovigilance, now and in the Future.- 2. Lost in Regulation.- 3. What is the Future of Pharmacovigilance and how can we Make it as Good as Possible?.- 4. Some Other Ideas About the Future of Pharmacovigilance.- 5. Best Safety Practices now and in the Future.- 6. Is There a Benefit from the Medical Literature Monitoring Service of the EMA?.- 7. The Unified Drug Safety-Clinical Database.- 8. Behind the Scenes – ‘Silent Factors’ Influencing Pharmacovigilance Practice and Decisions.- 9. Shaking up Culture and Communication in PV [V6].- 10. Broadening the Scope of Pharmacovigilance.- 11. Effective Treatment Matters: Revitalizing Pharmacoviglance.- 12. There are More Weber-Effects.- 13. Herbal and Traditional Medicines, Now and Future.- 14. The Concept of ‘Health’.- 15. Impact of Referral Procedures on the Interaction of RMP and PSUR.- 16. Other Sources of Information for Monitoring Drug Safety: Now and in the Future.- 17. Ecopharmacovigilance.