Good clinical practices tutorial- v7.015--shehnaz_june-10_v 3.0

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Shehnaz Vakharia

Santé & Médecine Business

Disclaimer ,[object Object],[object Object],[object Object]

Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory Framework in INDIA Drugs Controller General of India (DCGI) Ministry of Health Central Drug Standards Control Organization Permission to Conduct Clinical Trials In India

Applicable Local Regulations ,[object Object],[object Object],[object Object]

India Advantage ,[object Object],[object Object]

India Advantage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

India Advantage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],http://www.ey.com/Publication/vwLUAssets/Clinical_research_in_India_-_26_August/$FILE/Clinical%20research%20in%20India_FINAL%2826%20Aug%29.pdf http://www.ficci.com/PressRelease/508/GLOBAL-PHARMA.pdf Ref Ernest and Young / FICCI Report, (26 Aug 2009)

Challenges & Issues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],Significant Issues

[object Object],[object Object],Challenges & Issues

Challenges & Issues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],Challenges & Issues

[object Object],[object Object],[object Object],[object Object],Other Challenges

Other Challenges ,[object Object],[object Object],[object Object],[object Object]

Example-Infrastructure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Positive Developments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

http://www.accessdata.fda.gov/scripts/cder/CLIIL/index.cfm?fuseaction=Search.ShowAdvancedSearchResults&SortField=InspectionType&SortRequest=1&NewSearch=0

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],US FDA Inspection Results

QUESTIONS? ,[object Object],[object Object],[object Object],[object Object],[object Object]

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Good clinical practices tutorial- v7.015--shehnaz_june-10_v 3.0

1. GCP Issues Related to Conducting Clinical Trials in India Shehnaz Vakharia, MSc Principal Consultant Theraverity

4. Regulatory Framework in INDIA Drugs Controller General of India (DCGI) Ministry of Health Central Drug Standards Control Organization Permission to Conduct Clinical Trials In India

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19. http://www.accessdata.fda.gov/scripts/cder/CLIIL/index.cfm?fuseaction=Search.ShowAdvancedSearchResults&SortField=InspectionType&SortRequest=1&NewSearch=0

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21. CDSCO-US FDA Collaboration

22. Advantage Issues

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