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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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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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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