Clinical Research and Pharmacovigilance is popular PDF and ePub book, written by Ravi Humbarwadi in 2016-01-04, it is a fantastic choice for those who relish reading online the Uncategoriezed genre. Let's immerse ourselves in this engaging Uncategoriezed book by exploring the summary and details provided below. Remember, Clinical Research and Pharmacovigilance can be Read Online from any device for your convenience.
Clinical Research and Pharmacovigilance Book PDF Summary
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
Detail Book of Clinical Research and Pharmacovigilance PDF
- Author : Ravi Humbarwadi
- Release : 04 January 2016
- Publisher : Createspace Independent Publishing Platform
- ISBN : 1518685684
- Genre : Uncategoriezed
- Total Page : 358 pages
- Language : English
- PDF File Size : 13,7 Mb
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