Pharmacovigilance

Since publication of the first edition of PHARMACOVIGILANCE, relevant concepts have moved forwards very rapidly with the publication by the EMEA of a guidance on risk management, and the publication of three guidance documents by the FDA relating to good pharmacovigilance and pharmacoepidemiology practices, premarketing risk assessment, and the development and use of risk minimisation action plans (RiskMAPs). These rapid strides forwards have required a new edition of PHARMACOVIGILANCE, for the subject remains an area of ever-increasing research endeavour and activity. The Editors have built on the success of the first edition by expanding the content to include reporting in Germany and Japan, plus a wider range of organ classes and current topics. Otherwise the book retains its structure and purpose - to be a comprehensive volume on the whole area of Pharmacovigilance. It would be useful to anyone, medic or scientist, new or highly experienced, working in drug safety and may be even more important to those working in medical affairs where drug safety is just one of the functions with which they are involved ?.this would also be an excellent book to read in preparation for the Dip. Pharm. Med. Exam . Pharmaceutical Physician