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

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Shehnaz Vakharia
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GCP Issues Related to Conducting Clinical Trials in India Shehnaz Vakharia, MSc Principal Consultant Theraverity
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],[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
CDSCO-US FDA Collaboration
Advantage Issues
QUESTIONS? ,[object Object],[object Object],[object Object],[object Object],[object Object]

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