Pharmacovigilance: A Practical Approach
Published on 2. August 2018
Book
Paperback/Softback
228 pages
978-0-323-58116-5 (ISBN)
Description
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, Cheryl Renz, 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.
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.
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.
More details
Language
English
Place of publication
Philadelphia
United States
Target group
Professional and scholarly
Illustrations
Approx. 100 illustrations (100 in full color)
Dimensions
Height: 235 mm
Width: 191 mm
Weight
480 gr
ISBN-13
978-0-323-58116-5 (9780323581165)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Book
03/2025
2nd Edition
Churchill Livingstone
€101.50
Shipment within 15-20 days
Additional editions
Thao Doan MD | Linda Scarazzini MD | Cheryl Renz
Pharmacovigilance: A Practical Approach
E-Book
07/2018
Elsevier
€76.99
Available for download
Persons
Thao Doan is 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 is Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States. Fabio Lievano isVice 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, United States.
Editor
Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USA
Senior Medical Director, Safety Science, Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois, United States
Head, Benefit-Risk Management, Innovative Platforms Initiative & Epidemiology, Pharmacovigilance and Patient Safety, AbbVie Inc., Chicago. IL
Content
Introduction
1. Does Regulation Drive Science or Does Science Drive Regulation?
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
13. Impact and Implications of Technology on Pharmacovigilance
14. The Future of Pharmacovigilance
1. Does Regulation Drive Science or Does Science Drive Regulation?
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
13. Impact and Implications of Technology on Pharmacovigilance
14. The Future of Pharmacovigilance