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Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach

9780323581165
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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.

Product Details
Elsevier
60180
9780323581165
9780323581165

Data sheet

Publication date
2018
Issue number
1
Cover
paperback
Pages count
228
Dimensions (mm)
197 x 240
Weight (g)
480

  • 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

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