Cobert's Manual of Drug Safety and Pharmacovigilance

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Jones & Bartlett Publishers, Apr 1, 2011 - Medical - 407 pages
2 Reviews
Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.
 

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In the Field of Drug Safety and Pharmacovigilance, this is the only available comprehensive resource. It is a great source for anyone who is interested in exploring this rapidly evolving field.

Contents

The Theory and Definitions of Drug Safety Pharmacoviligance
1
Clinical Trials Clinical Research Organizations Phases IIV and InvestigatorInitiated Trials
7
Spontaneous Postmarketing Adverse Events
15
The Theory of Drug Safety Pharmacovigilance
21
Adverse Events with New Chemical Entities Generics Excipients Placebos and Counterfeits
27
Acute and Chronic Late Occurring Adverse Events Adverse Events That Disappear Bendectin and Diethylstilbesterol
35
The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology
39
Where Data Reside
45
Risk What Is It? Risk Management and Assessment Risk Evaluation and Minimization Systems REMS and Risk Management Plans RMPs
187
The United States FDAs Three Risk Guidances of 2005
199
Data Management Committees and IRBsEthics Committees
211
Product Quality Issues
217
Drug Labeling
223
Pregnancy and Lactation
229
CIOMS
235
International Conference on Harmonization ICH
251

Regulations Directives Guidances and Laws
49
Children Elderly and Other Special Vulnerable Groups
55
Drug Interactions
61
AE Volume Quality Good Documentation Procedures and Medical Records
65
Seriousness Expectedness and Causality
69
Coding of AEs and Drug Names
79
Expedited and Aggregate Reporting in Clinical Trials
87
Postmarketing Spontaneous ICSRSAE Reporting
95
Periodic Adverse Drug Experience Reports PADERS NDA Periodic Reports and Periodic Safety Update Reports PSURs
103
Epidemiology and Pharmacoepidemiology What Are They? What Are Their Limitations and Advantages?
109
Signals and Signaling in the Context of Risk Management
115
Information Technology Databases and Computers
129
The United States Food and Drug Administration FDA and MedWatch
137
Chapter 22 The European Medicines Agency EMA EMEA
151
The Qualified Person for Pharmacovigilance
159
United Kingdom Medicines and Healthcare Products Regulatory Agency MHRA
163
Health CanadaSanté Canada
167
Australian Therapeutic Goods Administration TGA
169
The Uppsala Monitoring Centre
171
Data Privacy and Security
173
The Roles and Interactions of Companies Governments Nongovernmental Organizations NGOs and Others in the World of Pharmacovigilance
179
Pharmaceutical Companies
267
Universities and Academic Medical Centers
271
Organization of a Typical Drug Safety Department
275
How an Individual Case Safety Report ICSR Is Handled from Start to Finish
283
The Safety Departments Role in Clinical Research Marketing and Sales Labeling Regulatory Due Diligence and Legal Issues
293
SOPs Working Documents Manuals Guidelines
301
Training
307
Vaccinovigilance
311
Toxic Effects of Immunogenicity to Biopharmaceuticals
317
Business Partners and Exchange of Safety Data
321
Audits and Inspections
329
SummaryDescription of PV Systems and RiskBased Inspections
337
Ethical Issues and Conflicts of Interest
343
Vigilance of Natural Health Products
351
RealWorld Issues Fialuridine
361
RealWorld Issues FenPhen
365
RealWorld Issues Nomifensine
367
Web Resources
369
Abbreviations
395
Index
399
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