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…
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…
