Pharmacovigilance aims to review and study the concept of monitoring drug safety. The objectives are to understand the concept of pharmacovigilance, important considerations for clinical trials, and to study the appendices of Schedule Y. The document will cover the introduction, need, historical background, terminology, process, program in India, and applications of pharmacovigilance.

1. 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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2. 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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3. CONTENTS…..
1. AIM AND OBJECTIVE
2.INTRODUCTION TO PHARMACOVIGILANCE.
3. NEED FOR PHARMACOVIGILANCE
4. HISTORICAL BACKGROUND
5. TERMINOLOGIES
6. PHARMACOVIGILANCE PROCESS
7. PHARMACOVIGILANCE PROGRAMME IN INDIA
8. APPLICATION OF PHARMACOVIGILANCE
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