Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

       Frequently Asked Questions

       Chapter 3Spontaneous Post-marketing Adverse Events

       Introduction

       United States Regulations

       European Union Requirements

       Other Regions

       Process Issues

       Frequently Asked Questions

       Chapter 4The Theory of Drug Safety — Pharmacovigilance

       A Brief History of the FDA

       Regulations, Laws, and Guidances

       The United States Regulations and Guidances

       The European Union Legislation (including Directives and Regulations), and Guidance

       Frequently Asked Questions

       Chapter 5The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology

       Introduction

       Case Report or Individual Case Safety Report

       Aggregate Reports

       Reporting Rates versus Risk

       Why We Can’t Calculate Good Rates

       Quantitative Signal Detection Methods

       Other Data Mining Methods

       Chapter 6Epidemiology and Pharmacoepidemiology: What Are They?

       What Are Their Limitations and Advantages?

       Introduction

       Randomized Controlled Trial

       Adaptive Clinical Trials

       Cohort Study

       Case-Control Study

       Nested Case-Control Study

       Confidence Intervals

       Frequently Asked Questions

       Chapter 7Regulations, Directives, Guidance, Laws and Consensus Documents

       United States

       European Union

       Consensus Documents

       The Practice

       Over-the-Counter Drugs

       United States

       European Union

       Staying Up to Date

       Scientific/Medical Literature

       Meetings and Conferences

       The Internet

       Chapter 8The United States Food and Drug Administration

       Introduction

       Center for Drug Evaluation and Research

       The Safety Reporting Portal