32 Data Management Committees and IRBs/Ethics Committees Data Management Committees Over the years, in addition to Investigational Review Boards (IRBs), the concept of a separate and additional independent group to…
26 Australia Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA), located near Canberra, is charged with drug and device safety for Australia. AE Reporting The reporting of adverse…
52 Real-World Issues: Fialuridine Fialuridine (FIAU) was a drug used to treat hepatitis B virus (HBV) in the early 1990s. Its use in one clinical trial in particular produced seven…
7 The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology This chapter is not intended to be a reference on statistics, epidemiology, or the technical mathematical aspects of…
43 SOPs, Working Documents, Manuals, Guidelines United States, European Union, and other health authority regulations require that companies have written standard operating procedures (SOPs) to handle drug safety and pharmacovigilance….
12 AE Volume, Quality, Good Documentation Procedures, and Medical Records In spite of all the difficulties inherent in the system for collecting and analyzing Adverse Events (AEs), the number of…
9 Regulations, Directives, Guidances, and Laws Pharmacovigilance (PV) is governed by a large body of requirements. Some are written and rigid. Others are written and far less rigid. Others are…
25 Health Canada/Santé Canada Health Canada is the federal department in the Canadian government responsible for health matters, including pharmacovigilance. Their remit includes foods, drugs, devices, and many other areas…
6 Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear (Bendectin), and Diethylstilbesterol Adverse events (AEs) seen shortly after starting or stopping drugs are common and relatively easy…
11 Drug Interactions Analyzing AEs and ascribing the causality to a particular drug can be quite difficult. This difficulty, however, is magnified when the patient also takes additional drugs. This…
