Clinical trial

1. SCHEDULE Y
‘ CLINICAL TRIAL ’
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 Clinical Trial.
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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3. CONTENTS…..
1. AIM AND OBJECTIVE
2.INTRODUCTION TO SCHEDULE Y
3.IMPORTANT CONSIDERATIONS FOR CLINICAL TRIALS
4. APPENDICES OF SCHEDULE Y
5. CONCLUSION
6. REFERENCES
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5. 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
India
2. Appendices of Schedule Y
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23. CONCLUSION
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