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
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