Chapter 1: The Theory & Definitions of Drug Safety (Pharmacovigilance)
Chapter 2: Clinical Trials, CROs, Phases I-IV, Investigator Initiated Trials
Chapter 3: Spontaneous, Post-Marketed AEs
Chapter 4: The Theory of Drug Safety (Pharmacovigilance)
Chapter 5: AEs with New Chemical Entities, Generics, Excipients and Placebos
Chapter 6: Acute and Chronic (Late Ocurring) AEs, AEs that disappear (BendectineTM), Diethylstilbesterol (DES)
Chapter 7: The Mathematics of AEs
Chapter 8: Organizations: The Food and Drug Administration (FDA)
-MedWatch
Chapter 9: Organizations: European Medicines Evaluation Agency
Chapter 10: Where Data Resides
Chapter 11: Signals and Signaling in the Context of Risk Management
Chapter 12: Data Privacy and Sharing
Chapter 13: The Roles of Academia, Companies, Government Health Authorities, Non-Governmental Organizations (NGOs), Consumer Groups, and Gadflies in the World of Pharmacovigilance
Chapter 14: What is It? Risk Management and Assessment
Chapter 15: FDA's Pre-Marketing Risk Assessment Guidance of March 2005
Chapter 16: FDA's Development and Use of Risk Minimization Action Plans Guidance of March 2005
Chapter 17: FDA's Good Pharmacovigilance Practices and Pharmacoepidemologic Assessment Guidance of March 2005
Chapter 18: Epidemiology and Pharmacoepidemiology
-What are They?
-What are Their Limitations and Advantages?
Chapter 19: Product Quality Issues
Chapter 20: Pregnancy, Lactation, and AEs
-AEs in Pregnant Partners of Males Taking a Drug
-Pregnancy Registries
-The Swedish Pregnancy Registry
Chapter 21: Children, the Elderly, and Other Special Groups
Chapter 22: Drug Interactions and Polypharmacy
Chapter 23: Drug Labeling, Warnings, etc.
-Physicians' Desk Reference (PDR) and Equivalents
-Differences from Country to Country
Chapter 24: Regulations, Directives, Guidance, Law and Practice in the EU and US
-CIOMS and ICH Documents
-What is Written Down and What is Traditional Practice
Chapter 25: CIOMS and CIOMS Reports
Chapter 26: ICH Reports
Chapter 27: Pharmaceutical Companies
Chapter 28: Universities and Academic and Non-Academic Medical Centers
Chapter 29: Organization and Structure of a Typical Safety Department
Chapter 30: Business Partners and AE Exchange Agreements
Chapter 31: Computers, Informatics, Validation, Data Entry
-E2B
Chapter 32: SOPs, Guidelines, etc.
Chapter 33: Training
Chapter 34: The Safety Department's Role in Clinical Research, Marketing and Sales, Labeling, Regulatory, Due Diligence and Legal Issues
Chapter 35: AE Volume, Quality and Medical Records
Chapter 36: How an AE is Handled in the Company from Start to Finish
Chapter 37: Seriousness, Expectedness, and Causality
Chapter 38: Coding of AEs: MedDRA® and Coding Conventions
-Conventions and Arbitrary Usage
-Drug Dictionaries and Drug Naming Problems
-When a Drug has a Different Name in Different Countries
Chapter 39: IND Reports: 7 and 15 Day Reports,
-IND Annual Reports
Chapter 40: NDA Reports: 15 Day Alert Reports
Chapter 41: NDA Reports: Periodic Reports
Chapter 42: The Tome
-FDA's Proposed 2003 Regulations
Chapter 43: Periodic Safety Update Reports (PSURs)
Chapter 44: Business Partners and Exchange of Safety Data
-Due Diligence
Chapter 45: Audits and Inspections
Chapter 46: Ethical Issues: Conflicts of Interest
Chapter 47: Some Real-World Safety Issues and Controversies: FIAU
Chapter 48: Some Real-World Safety Examples and Issues: Fen-Phen
Chapter 49: Some Real-World Safety Examples and Issues: Nomifensine
Chapter 50: Some Real-World Safety Examples and Issues: Vioxx®, Dr. Graham et al
