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Introduction: Updated from Second Edition

History of Pharmacovigilance

Legal Basis: European Union

Ethical Oversight, Consent, and Confidentiality

Pharmacovigilance‐Related Topics at the Level of the International Conference on Harmonisation

The Council for International Organizations of Medical Sciences Working Groups and Their Contributions to Pharmacovigilance

Terminologies in Pharmacovigilance

Nonclinical Toxicological Support for Phase I Trials

The Evaluation of Adverse Events in Clinical Trials (with a Particular Focus on the Use of Meta‐Analysis)

Case Reports as Evidence in Pharmacovigilance

Periodic Safety Update Reports

The Principles behind Risk Management in the European Union

Regulatory Pharmacovigilance in the European Union

Spontaneous Reporting: United Kingdom

Spontaneous Reporting: France

How Pharmacovigilance is Organized in Germany

Organization of Pharmacovigilance in the Netherlands

Pharmacovigilance in Spain

Italian Pharmacovigilance System

Pharmacovigilance in Turkey

Spontaneous Reporting and Pharmacovigilance Practice: USA

Spontaneous Reporting in Mexico

Pharmacovigilance in Argentina: A Lot Done, A Lot To Do

Pharmacovigilance and Risk Management in Japan

Pharmacovigilance in Hong Kong

Pharmacovigilance in China

China

Malaysia

Philippines

Singapore

Thailand

Vietnam

Pharmacovigilance in India

Pharmacovigilance in New Zealand

Pharmacovigilance: Australia

Pharmacovigilance in Africa

Vaccine Safety Surveillance

How We Assess Causality

Quantitative Signal Detection and Analysis in Pharmacovigilance

Self‐Controlled Case Series Analysis

Prescription–Event Monitoring (PEM): The Evolution to the New Modified PEM and its Support of Risk Management

Prescription–Event Monitoring in New Zealand

A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology

Overview of North American Databases

The Clinical Practice Research Datalink: The New 54 Million Fully Integrated Research Data and Clinical Trial System

Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative

Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU‐ADR Experience

Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership

Mechanisms of Adverse Drug Reactions

Fatal Medication Errors and Adverse Drug Reactions

Dermatological Adverse Drug Reactions

Gastrointestinal Adverse Drug Reactions

Hematological Adverse Drug Reactions

Hepatic Adverse Drug Reactions

Ocular Side Effects of Prescription Medications

Renal Adverse Drug Reactions

The Cardiovascular Spectrum of Adverse Drug Reactions

Neurological Adverse Events

Drug Safety in Pregnancy

Pharmacovigilance in Pediatrics

Drugs and the Elderly

Anesthetic Adverse Drug Reactions

Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies

Surveillance for Medical Devices: USA

The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents

Nonsteroidal Anti‐inflammatory Drugs – Cyclooxygenase‐2 Inhibitors: Risks and Benefits

Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences

Design and Implementation of Surveys to Assess Patient and Healthcare Provider Understanding of Risks and Safe Use Conditions

Eu2P: The First European Online Public–Private Joint Training Program in Pharmacovigilance and Pharmacoepidemiology

Teaching and Learning Pharmacovigilance

Practical Experience in Teaching Pharmacovigilance

An Historical Perspective of the Future of Pharmacovigilance

Index

Front Matter

Color Plates