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Elsevier

Pharmacovigilance: A Practical Approach

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 me… Leer más

Descripción

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.

Puntos claves

  • 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

De interès para

Pharmacologists, clinician-scientists across disciplines, patient safety specialists

Índice

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

Detalles del producto

Sobre los editores

TD

Thao Doan

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
Afiliaciones y experiencia
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

LS

Linda Scarazzini

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.
Afiliaciones y experiencia
Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, USA

CR

Cheryl Renz

Afiliaciones y experiencia
Senior Medical Director, Safety Science, Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois, United States

FL

Fabio Lievano

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.
Afiliaciones y experiencia
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

MB

Mondira Bhattacharya

Afiliaciones y experiencia
Head, Benefit-Risk Management, Innovative Platforms Initiative & Epidemiology, Pharmacovigilance and Patient Safety, AbbVie Inc., Chicago. IL

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