Post on 18-Dec-2014
description
transcript
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