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Some years ago there was very little in the way of pharmacovigilance regulation. Today there is a vast amount of guidance and regulation to consider. These requirements are rapidly changing and it is challenging for professionals to keep abreast of everything.
This book focuses on the principles of pharmacovigilance rather than on every small detail of the guidelines and regulations, which will inevitably change. It is relevant to everyone involved in pharmacovigilance, both directly and indirectly through their role. Specialists will, of course, need to familiarise themselves with the applicable rules and regulations issued by the national regulators (eg. the European Medicines Agency and the US FDA). The International Council for Harmonisation also pioneers the global development of safety-related guidance, particularly within the E2 guidelines, so awareness of these is also important.
The book complements the series of online training courses in pharmacovigilance that Lisbeth and Professor David Hutchinson have developed. Details are available on the Brookwood website at http://www.brookwood4pv.training/
Lisbeth Tofte Hemmingsen is a highly experienced specialist in quality assurance and pharmacovigilance. She has dealt with the most robust of regulatory authority inspections during her time in the pharmaceutical industry. She has subsequently advised many organizations on both quality management and pharmacovigilance. There is no one better to write this book and to share with you her wide experience in this rapidly evolving field.