Basicmedical Key

38 Pharmaceutical Companies There are many types of companies and institutions in the pharmaceutical world with responsibilities regarding drug safety. A summary of various types of institutions follows. There are…

14 Coding of AEs and Drug Names As pharmacovigilance becomes more mechanized and computerized, the need for standard terminologies, formats, dictionaries, narratives, and abbreviations grows. The first two major areas…

5 Adverse Events with New Chemical Entities, Generics, Excipients, Placebos, and Counterfeits Are some adverse events (AEs) created more equal than others? Are some AEs more important than others? Why…

31 The United States FDA’s Three Risk Guidances of 2005 In March 2005, the U.S. Food and Drug Administration (FDA) issued three guidances, which were years in the making, summarizing…

33 Product Quality Issues In the past several years, it has been realized that many other issues in addition to bad reactions to the active chemical entity in the product…

2 Clinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated Trials To obtain approval to market a new drug in the United States, Canada, the European Union, and most other…

23 The Qualified Person for Pharmacovigilance For companies with products sold in the European Union, Volume 9A requires that there be a “Qualified Person for Pharmacovigilance” (QPPV or QP). This…

27 The Uppsala Monitoring Centre The Uppsala Monitoring Centre (UMC), in addition to maintaining three databases (Vigibase, WHO Drug Dictionary Enhanced, and WHO-ART; see Chapter 14) also provides many services…