Kurztext

Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognised adverse drug reactions thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe. As a discipline, pharmacovigilance impacts on many specialist areas such as pharmacoepidemiology, medical practice, public health, but is most intimately linked to clinical research, development and drug licensing. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities.
The Dictionary of Pharmacovigilance contains a comprehensive list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.
Written by someone with excellent knowledge of pharmacovigilance gained from working in industry and regulatory authority. This book will be essential reference for pharmacovigilance and regulatory affairs professionals worldwide.

420 p.
hard cover

Deutscher Apotheker Verlag

Autoren