Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Key Features
- Covers the evolving regulatory landscape, as well as current and future use of digital technologies.
- Uses case studies to ensure content is relevant to everyday practice.
- Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance.
- Consolidates today’s available information on this timely topic into one convenient resource.
Author Information
Edited by Thao Doan, MD, Group Medical Director, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Department of Pharmacology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Linda Scarazzini, MD, Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USA; Cheryl Renz, Senior Medical Director, Safety Science, Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois, United States; Fabio Lievano, MD, PhD H.C., Vice President, Patient Safety, Scientific Collaborations, and New Business Advancement, Pharmacovigilance and Patient Safety, Epidemiology and, R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Northwestern University Feinberg School of Medicine, Chicago, IL, USA and Mondira Bhattacharya, MD, Head, Benefit-Risk Management, Innovative Platforms Initiative & Epidemiology, Pharmacovigilance and Patient Safety, AbbVie Inc., Chicago. IL
Introduction
Section I. The Regulatory Enviroment
1. Does Regulation Drive Science or Does Science Drive Regulation?
Section II. Data and Real World Evidence
2. Role of Epidemiology in Pharmaceutical Industry
3. Real World Epidemiologic Studies and Patient Registries
Section III. Benefit-Risk in the Drug Development Life Cycle
4. Signal Management and Methods of Signal Detection
5. Causality Assessment and Examples of Adverse Drug Reactions (Drug Induced Liver Injury, Skin, Major Adverse Cardiac Events and Renal)
6. Product Safety Monitoring in Clinical Trials
7. Benefit-Risk Assessments
8. Communicating benefit risk
9. Pharmacovigilance and Medical Devices
10. Vaccine Safety Surveillance
11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)
12. Pharmacovigilance in Pregnancy
Section IV. The Role of the Digital Revolution
13. Impact and Implications of Technology on Pharmacovigilance
Section V. The Next Frontier
14. The Future of Pharmacovigilance
