Clinical Research And Pharmacovigilance

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9781518685682: Clinical Research And Pharmacovigilance
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CLINICAL RESEARCH & CLINICAL TRIALS 1. NEW DRUG DEVELOPMENT 2. HISTORICAL EVENTS 3. GOOD CLINICAL PRACTICE – ICH GCP 4. CLINICAL TRIAL DESIGN 5. SERIOUS ADVERSE EVENT – SAE 6. SITE 7. PHARMACODYNAMICS 8. PHARMACOKINETICS 9. BIOAVAILABILITY 10. BIOEQUIVALENCE 11. QC AND QA IN CLINICAL TRIALS 12. CLINICAL DATA MANAGEMENT 13. PHARMACOVIGILANCE 14. GIPV – ONLINE PHARMACOVIGILANCE 1. INTRODUCTION 2. NEED FOR PHARMACOVIGILANCE 3. DEFINITIONS 4. TYPES OF REPORTS 5. REPORTING PROCESS 6. SPONTANEOUS REPORTS 7. TIME FRAMES FOR REGULATORY REPORTING 8. CIOMS FORM 9. MEDDRA 10. MEDDRA – A PERSPECTIVE 11. WHO DRUG DICTIONARYVE 12. ACTION TAKEN, DC AND RC 13. CAUSALITY ASSESSMENT 14. UNBLINDING & SUSAR 15. POST TREATMENT AND PRE-TREATMENT STUDY 16. WORKFLOW 17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE. 18. EMEA- GVP 19. FDA: ADJUDICATION AND ADVISORY PANEL 20. BACK TO THE FUTURE: VIOXX, MEDIATOR & THALIDOMIDE 21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE 22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA 23. SIGNAL DETECTION 24. PROCESS OF SIGNAL DETECTION 25. ARGUS 26. NARRATIVE WRITING – RULES & FORMAT 27. IMPORTANT MEDICAL EVENT LIST 28. GLOSSARY 29. THE PHARMACOVIGILANCE INTERVIEW 30. SERIOUS VS NON-SERIOUS: CASE STUDY & THUMB RULES

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About the Author:

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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Book Description Createspace Independent Publishing Platform, 2016. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****. CLINICAL RESEARCH CLINICAL TRIALS 1. NEW DRUG DEVELOPMENT 2. HISTORICAL EVENTS 3. GOOD CLINICAL PRACTICE - ICH GCP 4. CLINICAL TRIAL DESIGN 5. SERIOUS ADVERSE EVENT - SAE 6. SITE 7. PHARMACODYNAMICS 8. PHARMACOKINETICS 9. BIOAVAILABILITY 10. BIOEQUIVALENCE 11. QC AND QA IN CLINICAL TRIALS 12. CLINICAL DATA MANAGEMENT 13. PHARMACOVIGILANCE 14. GIPV - ONLINE PHARMACOVIGILANCE 1. INTRODUCTION 2. NEED FOR PHARMACOVIGILANCE 3. DEFINITIONS 4. TYPES OF REPORTS 5. REPORTING PROCESS 6. SPONTANEOUS REPORTS 7. TIME FRAMES FOR REGULATORY REPORTING 8. CIOMS FORM 9. MEDDRA 10. MEDDRA - A PERSPECTIVE 11. WHO DRUG DICTIONARYVE 12. ACTION TAKEN, DC AND RC 13. CAUSALITY ASSESSMENT 14. UNBLINDING SUSAR 15. POST TREATMENT AND PRE-TREATMENT STUDY 16. WORKFLOW 17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE. 18. EMEA- GVP 19. FDA: ADJUDICATION AND ADVISORY PANEL 20. BACK TO THE FUTURE: VIOXX, MEDIATOR THALIDOMIDE 21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE 22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA 23. SIGNAL DETECTION 24. PROCESS OF SIGNAL DETECTION 25. ARGUS 26. NARRATIVE WRITING - RULES FORMAT 27. IMPORTANT MEDICAL EVENT LIST 28. GLOSSARY 29. THE PHARMACOVIGILANCE INTERVIEW 30. SERIOUS VS NON-SERIOUS: CASE STUDY THUMB RULES. Seller Inventory # APC9781518685682

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Book Description Createspace Independent Publishing Platform, 2016. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****.CLINICAL RESEARCH CLINICAL TRIALS 1. NEW DRUG DEVELOPMENT 2. HISTORICAL EVENTS 3. GOOD CLINICAL PRACTICE - ICH GCP 4. CLINICAL TRIAL DESIGN 5. SERIOUS ADVERSE EVENT - SAE 6. SITE 7. PHARMACODYNAMICS 8. PHARMACOKINETICS 9. BIOAVAILABILITY 10. BIOEQUIVALENCE 11. QC AND QA IN CLINICAL TRIALS 12. CLINICAL DATA MANAGEMENT 13. PHARMACOVIGILANCE 14. GIPV - ONLINE PHARMACOVIGILANCE 1. INTRODUCTION 2. NEED FOR PHARMACOVIGILANCE 3. DEFINITIONS 4. TYPES OF REPORTS 5. REPORTING PROCESS 6. SPONTANEOUS REPORTS 7. TIME FRAMES FOR REGULATORY REPORTING 8. CIOMS FORM 9. MEDDRA 10. MEDDRA - A PERSPECTIVE 11. WHO DRUG DICTIONARYVE 12. ACTION TAKEN, DC AND RC 13. CAUSALITY ASSESSMENT 14. UNBLINDING SUSAR 15. POST TREATMENT AND PRE-TREATMENT STUDY 16. WORKFLOW 17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE. 18. EMEA- GVP 19. FDA: ADJUDICATION AND ADVISORY PANEL 20. BACK TO THE FUTURE: VIOXX, MEDIATOR THALIDOMIDE 21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE 22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA 23. SIGNAL DETECTION 24. PROCESS OF SIGNAL DETECTION 25. ARGUS 26. NARRATIVE WRITING - RULES FORMAT 27. IMPORTANT MEDICAL EVENT LIST 28. GLOSSARY 29. THE PHARMACOVIGILANCE INTERVIEW 30. SERIOUS VS NON-SERIOUS: CASE STUDY THUMB RULES. Seller Inventory # APC9781518685682

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