Cobert’s Manual of Drug Safety and Pharmacovigilance 3rd Edition – Digital Instant Dowload.

Product details:

• ISBN-10 ‏ : ‎ 9811215235
• ISBN-13 ‏ : ‎ 978-9811215230
• Author: Barton Cobert, William Gregory, Jean-loup Thomas

Completely revised and updated, Cobert’s Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. Cobert’s Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Table contents:

Basics The Theory and Definitions of Drug Safety (Pharmacoviligance);

Spontaneous Postmarketing Adverse Events;

Regulations, Directives, Guidances, and Laws;

The Qualified Person for Pharmacovigilance;

Children, Elderly, and Other Special (Vulnerable) Groups;

Drug Interactions;

Seriousness, Expectedness, and Causality;

Signals and Signaling in the Context of Risk Management;

Organization of a Typical Drug Safety Department;

Ethical Issues and Conflicts of Interest;

Vaccinovigilance;

Data Privacy and Security;

Real-World Issues: Fialuridine,

Fen-Phen,

Nomifensine; Marijuana; and other papers

Title tag:

1. Cobert’s Manual of Drug Safety and Pharmacovigilance 3rd Edition – Essential Guide for Healthcare Professionals
2. Stay Informed on Drug Risks with Cobert’s Manual of Drug Safety & Pharmacovigilance 3rd Ed
3. Master Drug Safety Practices with the Third Edition of Cobert’s Pharmacovigilance Manual