Overview

CLINICAL RESEARCH & CLINICAL TRIALS1. NEW DRUG DEVELOPMENT2. HISTORICAL EVENTS3. GOOD CLINICAL PRACTICE - ICH GCP4. CLINICAL TRIAL DESIGN5. SERIOUS ADVERSE EVENT - SAE6. SITE7. PHARMACODYNAMICS8. PHARMACOKINETICS9. BIOAVAILABILITY10. BIOEQUIVALENCE11. QC AND QA IN CLINICAL TRIALS12. CLINICAL DATA MANAGEMENT13. PHARMACOVIGILANCE14. GIPV - ONLINEPHARMACOVIGILANCE1. INTRODUCTION2. NEED FOR PHARMACOVIGILANCE3. DEFINITIONS4. TYPES OF REPORTS5. REPORTING PROCESS6. SPONTANEOUS REPORTS7. TIME FRAMES FOR REGULATORY REPORTING8. CIOMS FORM9. MEDDRA10. MEDDRA - A PERSPECTIVE11. WHO DRUG DICTIONARYVE12. ACTION TAKEN, DC AND RC13. CAUSALITY ASSESSMENT14. UNBLINDING & SUSAR15. POST TREATMENT AND PRE-TREATMENT STUDY16. WORKFLOW17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE.18. EMEA- GVP19. FDA: ADJUDICATION AND ADVISORY PANEL20. BACK TO THE FUTURE: VIOXX, MEDIATOR & THALIDOMIDE21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA23. SIGNAL DETECTION24. PROCESS OF SIGNAL DETECTION25. ARGUS 26. NARRATIVE WRITING - RULES & FORMAT27. IMPORTANT MEDICAL EVENT LIST28. GLOSSARY29. THE PHARMACOVIGILANCE INTERVIEW30. SERIOUS VS NON-SERIOUS: CASE STUDY & THUMB RULES

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9781518685682

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The Author is a physician qualified in clinical research. He has headed medical review of drug safety in a global corporate. In addition to the book on Clinical Research and Clinical Trials he has also written boons on Pharmacovigilance, Pharmacoepidemiology and Database. He is also an experienced trainer in these domains.

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