Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach

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Elsevier - Health Sciences Division

08/2018

228

Mole

Inglês

9780323581165

15 a 20 dias

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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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