Includes bibliographical references and index.

Front Cover; Pharmacovigilance: A Practical Approach; Pharmacovigilance: A Practical Approach; Copyright; List of Contributors; Acknowledgments; Introduction; Contents; I -- THE REGULATORY ENVIRONMENT; 1 -- Does Regulation Drive Science or Does Science Drive Regulation?; INTRODUCTION; IMPORTANT EVENTS IN PHARMACOVIGILANCE; IMPORTANT PHARMACOVIGILANCE ORGANIZATIONS; IMPORTANT REGULATORY AUTHORITIES AND REGIONS; THE WORLD OF REGULATORY SCIENCE; EMA PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE; NEW WAVE OF GLOBAL PHARMACOVIGILANCE REGULATION; THE EU QPPV; THE RISE OF THE NATIONAL QPPV

The Pharmacovigilance System Master FileIs Regulatory Guidance Just Guidance?; How can Industry Influence Regulation?; Enforcement of Pharmacovigilance Regulations; CONCLUSIONS; REFERENCES; II -- SAFETY DATA AND REAL WORLD EVIDENCE; 2 -- Signal Management and Methods of Signal Detection; INTRODUCTION; SIGNALS (BOX 2.2); SIGNAL DETECTION; SIGNAL VALIDATION; SIGNAL ASSESSMENT; DETERMINING BENEFIT/RISK (BOX 2.5); SAFETY GOVERNANCE IN PHARMACOVIGILANCE; SAFETY GOVERNANCE FRAMEWORK; SAFETY OVERSIGHT BOARD (BOX 2.8); SAFETY MANAGEMENT TEAMS 18; FIRST-IN-HUMAN REVIEW COMMITTEE 19,20

INTERNAL SAFETY ADVISORY GROUPS SAFETY ASSESSMENT COMMITTEES 21; SAFETY GOVERNANCE SUPPORT; SAFETY GOVERNANCE PROCESS (BOX 2.11); CONCLUSION; LIST OF DEFINITIONS; REFERENCES; FURTHER READING; 3 -- Product Safety Monitoring in Clinical Trials; INTRODUCTION; SAFETY PLANNING; Systemic Approach; Development Risk Management Plan and Development Core Safety Information (Box 3.3); Specific Safety Issues (Box 3.4); DATA COLLECTION AND EVALUATION; Data Collection (Box 3.5); General principles and considerations; Specialized data collection and adjudication; Baseline risk factor documentation

Safety topics of interest Event adjudication; Data monitoring committee (Box 3.6); Safety assessment committees; Data Evaluation; Quantitative analysis; Individual studies (Box 3.8); Individual studies (Box 3.8); Meta-Analysis (Box 3.11); Meta-Analysis (Box 3.11); Qualitative analysis (Box 3.12); Signal evaluation; Safety actions in response to a confirmed signal-risk management (Box 3.13); REPORTING AND COMMUNICATION OF SAFETY INFORMATION; Expedited Reporting; Causality assessment of individual case safety report (Box 3.14); Communicating Safety Information (Box 3.16); Informed consent

Investigator brochure Development Safety Update Report; CONCLUSION; REFERENCES; 4 -- Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major ...; INTRODUCTION; THE CIOMS WORKING GROUP CRITERIA; THE BRADFORD-HILL CRITERIA; LIVER: CAUSALITY ASSESSMENT IN DRUG-INDUCED LIVER INJURY IN ADULTS; Step 1: Take History and Perform a Physical Examination; Step 2: Calculate the R-Value; Step 3: Exclude Differential Diagnoses; Step 4: Literature Review; Step 5: Clinical Judgement for Final Drug-Induced Liver Injury Diagnosis