PHARMACOVIGILANCE

PRESENTING BY,Ms.Sonali Diwate B.

M.Pharm (II Sem)

GUIDED BY,Prof. Chanshetti R.

MODERN C.O.P.,MOSHI, PUNE-412105

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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

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CONTENTS…..

1. AIM AND OBJECTIVE2.INTRODUCTION TO PHARMACOVIGILANCE.3. NEED FOR PHARMACOVIGILANCE4. HISTORICAL BACKGROUND5. TERMINOLOGIES6. PHARMACOVIGILANCE PROCESS7. PHARMACOVIGILANCE PROGRAMME IN INDIA8. APPLICATION OF PHARMACOVIGILANCE

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NEED FOR PHARMACOVIGILANCE ????

LIMITATIONS OF CLINICAL STUDY DATA

AIMS

TERMINOLOGIES

OBJECTIVES