Pharmacovigilance
29
PHARMACOVIGILANCE PRESENTING BY, Ms.Sonali Diwate B. M.Pharm (II Sem) GUIDED BY, Prof. Chanshetti R. MODERN C.O.P.,MOSHI, PUNE-412105 1
-
Upload
rxsonali -
Category
Health & Medicine
-
view
70 -
download
0
description
Pharmacovigilance
Transcript of Pharmacovigilance
PHARMACOVIGILANCE
PRESENTING BY,Ms.Sonali Diwate B.
M.Pharm (II Sem)
GUIDED BY,Prof. Chanshetti R.
MODERN C.O.P.,MOSHI, PUNE-412105
1
AIM To Review and Study the concept of Pharmacovigilance
OBJECTIVES:
1. TO UNDERSTAND CONCEPT OF PHARMACOVIGILANCE.
2. TO UNDERSTAND IMPORTANT CONSIDERATIONS FOR CLINICAL TRIALS
3. TO STUDY APPENDICES OF SCHEDULE Y
2
CONTENTS…..
1. AIM AND OBJECTIVE2.INTRODUCTION TO PHARMACOVIGILANCE.3. NEED FOR PHARMACOVIGILANCE4. HISTORICAL BACKGROUND5. TERMINOLOGIES6. PHARMACOVIGILANCE PROCESS7. PHARMACOVIGILANCE PROGRAMME IN INDIA8. APPLICATION OF PHARMACOVIGILANCE
3
NEED FOR PHARMACOVIGILANCE ????
LIMITATIONS OF CLINICAL STUDY DATA
AIMS
TERMINOLOGIES
OBJECTIVES