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Schedule ‘ Y ’
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SCHEDULE ‘ Y ’
PRESENTING BY,Ms.Sonali Diwate B.
M.Pharm (II Sem)
GUIDED BY,Prof. Shrivastav S.K.
MODERN C.O.P.,MOSHI, PUNE-412105
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AIM To Review and Study Schedule Y
OBJECTIVES:
1. TO UNDERSTAND CONCEPT OF CLINICAL TRIAL
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 SCHEDULE Y3.IMPORTANT CONSIDERATIONS FOR CLINICAL TRIALS4. APPENDICES OF SCHEDULE Y5. CONCLUSION6. REFERENCES
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SCHEDULE Y ???
“REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT &/OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS”
Schedule Y is mainly divided into two parts-
1. Important Considerations for Clinical Trials in India2. Appendices of Schedule Y
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CONCLUSION
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