18 Epidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages? This chapter is not meant to be an introduction to epidemiology or pharmacoepidemiology. There are many excellent…
13 Seriousness, Expectedness, and Causality The drug safety staff involved in individual case evaluation generally have to make several decisions regarding each case. These decisions must be made rapidly on…
37 International Conference on Harmonization (ICH) This chapter summarizes the purpose of the International Conference on Harmonization (ICH) and the reports issued by the various working groups related to drug…
45 Vaccinovigilance Lisa Beth Ferstenberg, MD Vigilance for vaccines is different from vigilance for drugs. We will review the difference between vaccinovigilance and pharmacovigilance—the U.S. Initiative: VAERS, the European Initiative:…
34 Drug Labeling Labeling is a general term encompassing many things about a drug. Labeling is divided for pharmacovigilance purposes into several different documents. For drugs that are not yet…
17 Periodic Adverse Drug Experience Reports (PADERS): NDA Periodic Reports and Periodic Safety Update Reports (PSURs) Most countries now accept and usually require the submission of Periodic Safety Reports for…
8 Where Data Reside There is an enormous amount of data collected in the course of doing pharmacovigilance work. Much of it is reliable and verified but much is not….
39 Universities and Academic Medical Centers Universities and academic medical centers have multiple areas in which they interact with the drug safety world: Discovery and licensing Specialized clinical research units…
49 Summary/Description of PV Systems and Risk-Based Inspections Companies doing business or clinical trials in the European Union must prepare and have on file a critical document known as the…
28 Data Privacy and Security Approximately 30 or so years ago, with the advent of enormous changes in communication, personal computers, and medicine and society (greater mobility, the ascent of…
