Mann's Pharmacovigilance

Content: Cover
 Title page
 Copyright page
 Contents
 Contributors
 Foreword
 1: Introduction: Updated from Second Edition
 Background
 Diagnosing Adverse Drug Reactions
 Current Methods of Pharmacovigilance
 Hypothesis-Generating Methods
 Spontaneous Adverse Drug Reaction Reporting
 Prescription-Event Monitoring
 Other Hypothesis-Generating Methods
 Hypothesis-Testing Methods
 Conclusion
 References
 2: History of Pharmacovigilance
 Early History of Drug Safety
 Recent History
 Pre-1962
 Turning Point: The Federal Food, Drug and Cosmetics Act
 Gradual Increase in Regulatory Authority. Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation
 United States of America
 United Kingdom
 Germany
 Scandinavia
 Japan
 World Health Organization
 France
 Special Issues in Pharmacovigilance
 Examples of Drugs that were Withdrawn from the Market
 Bendectin
 Thalidomide: Today\'s Approved Uses
 Pharmacovigilance is Not Just for Regulators
 References
 Part I: The Regulatory Basis of Pharmacovigilance
 3: Legal Basis: European Union
 Introduction
 Reorganization of the European Union Regulatory System. Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management
 Reporting Requirements
 Transparency and Communication
 Pharmacovigilance Enforcement
 Further Information about Proposed New Legislation and Guidelines
 4: Ethical Oversight, Consent, and Confidentiality
 Introduction
 Practical Implications of Ethical Oversight
 The Privacy and Security of Health Data
 The Linkage of Electronic Health Data
 The Conduct of Scientifically Sound Studies
 Ethical Oversight and Privacy Law and Resulting Dilemmas
 The Common Rule. State LawsThe Health Insurance Portability and Accountability Act
 Dilemmas Arising from the Health Insurance Portability and Accountability Act
 Directions for Future Ethical Oversight and Privacy Provisions
 References
 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1
 Introduction
 The International Conference on Harmonisation Step Process
 ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations
 ICH Step 2: Confirmation of Six Party Consensus
 ICH Step 3: Regulatory Consultation. ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations
 Pharmacovigilance-Related International Conference on Harmonisation Topics
 Topic ICH-E2A: Clinical Safety Data Management --
Definitions and Standards for Expedited Reporting
 ICH-E2D Topic: Post-Approval Safety Management --
Definitions and Standards for Expedited Reporting
 ICH-E2B Topic: Clinical Safety Data Management --
Data Elements for Transmission of Individual Case Safety Reports. ICH-E2C Topic: Clinical Safety Data Management --
Periodic Benefit-Risk Evaluation Report (PBRER).