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.
Table of Contents
- Chapter 1 The Theory and Definitions of Drug Safety (Pharmacoviligance)
- Chapter 2 Clinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated Trials
- Chapter 3 Spontaneous Postmarketing Adverse Events
- Chapter 4 The Theory of Drug Safety (Pharmacovigilance)
- Chapter 5 Adverse Events with New Chemical Entities, Generics, Excipients, Placebos, and Counterfeits
- Chapter 6 Acute and Chronic (Late Occurring) Adverse Events, Adverse Events that Disappear (BendectinTM), and Diethylstilbesterol
- Chapter 7 The Mathematics of Adverse Events and A Brief Note on Pharmacoepidemiology
- Chapter 8 Where Data Reside
- Chapter 9 Regulations, Directives, Guidances, and Laws
- Chapter 10 Children, Elderly, and Other Special (Vulnerable) Groups
- Chapter 11 Drug Interactions
- Chapter 12 AE Volume, Quality, Good Documentation Procedures, and Medical Records
- Chapter 13 Seriousness, Expectedness, and Causality
- Chapter 14 Coding of AEs and Drug Names
- Chapter 15 Expedited and Aggregate Reporting in Clinical Trials
- Chapter 16 Post Marketing Spontaneous ICSR/SAE Reporting
- Chapter 17 Periodic Adverse Drug Experience Reports (PADERS): NDA Periodic Reports and Periodic Safety Update Reports (PSURs)
- Chapter 18 Epidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages?
- Chapter 19 Signals and Signaling in the Context of Risk Management
- Chapter 20 Information Technology, Databases, and Computers
- Chapter 21 The US Food & Drug Administration (FDA) and MedWatch
- Chapter 22 The European Medicines Agency (EMA, EMEA)
- Chapter 23 The Qualified Person for Pharmacovigilance
- Chapter 24 UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Chapter 25 Health Canada/Santé Canada
- Chapter 26 Australian Therapeutic Goods Administration (TGA)
- Chapter 27 The Uppsala Monitoring Centre
- Chapter 28 Data Privacy and Security
- Chapter 29 The Roles and Interactions of Companies, Governments, Non-Governmental Organizations (NGOs), and Others in the World of Pharmacovigilance
- Chapter 30 Risk: What is it? Risk Management and Assessment, Risk Evaluation and Minimization Systems (REMS), and Risk Management Plans (RMPs)
- Chapter 31 The US FDA’s Three Risk Guidances of 2005
- Chapter 32 Data Management Committees and IRBs/Ethics Committees
- Chapter 33 Product Quality Issues
- Chapter 34 Drug Labeling
- Chapter 35 Pregnancy and Lactation
- Chapter 36 CIOMS
- Chapter 37 International Conference on Harmonization (ICH)
- Chapter 38 Pharmaceutical Companies
- Chapter 39 Universities and Academic Medical Centers
- Chapter 40 Organization of a Typical Drug Safety Department
- Chapter 41 How an Individual Case Safety Report (ICSR) is Handled from Start to Finish
- Chapter 42 The Safety Department’s Role in Clinical Research, Marketing and Sales, Labeling, Regulatory Due Diligence, and Legal Issues
- Chapter 43 SOPs, Working Documents, Manuals, Guidelines
- Chapter 44 Training
- Chapter 45 Vaccinovigilance
- Chapter 46 Toxic Effects of Immunogenicity to Biopharmaceuticals
- Chapter 47 Business Partners and Exchange of Safety Data
- Chapter 48 Audits and Inspections
- Chapter 49 Summary/Description of PV Systems and Risk Based Inspections
- Chapter 50 Ethical Issues and Conflicts of Interest
- Chapter 51 Vigilance of Natural Health Products
- Chapter 52 Real World Issues: Fialuridine
- Chapter 53 Real World Issues: Fen-Phen
- Chapter 54 Real World Issues: Nomifensine
About the Author
Barton Cobert, MD, FACP, FACG, FFPM-President, BLCMD Associates LLC, Westfield, New Jersey, has had a long career in the clinical practice of Gastroenterology and Internal Medicine as well as, in the pharmaceutical industry specializing in drug safety and risk management. For over a decade he was Global Head of Drug Safety (side effects) for the Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert was born in New York City and received his BA from New York University and his MD from New York University School of Medicine. He is board certified in Internal Medicine and Gastroenterology. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally on drug safety, side effects and the safe use of medications. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety. Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company in Westfield, NJ.
Product Details
- Paperback: 408 pages
- Publisher: Jones & Bartlett Learning; 2 edition (2011)
- Language: English
- ISBN-10: 0763791598
- ISBN-13: 978-0763791599
- Product Dimensions: 10.8 x 8.5 x 1.1 inches
List Price: $86.95