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Regulatory Aspects Dev En

Regulatory Aspects Dev En

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Published by Narendrakumar

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Published by: Narendrakumar on Jan 08, 2009
Copyright:Attribution Non-commercial

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06/16/2009

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Training Workshop on PharmaceuticalDevelopment
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Regulatory Aspects of ProductDevelopmentICH Process Q8, Q9, Q10
WHO Workshop, October 2007
Sultan Ghani, Director Bureau of Pharmaceutical SciencesTherapeutic Products Directorate, Health Canada
 
Training Workshop on PharmaceuticalDevelopment
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Focus of Presentation
ICH Process
ICH Q8, Q9, Q10
Pharmaceutical Development
 
Training Workshop on PharmaceuticalDevelopment
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ICH
BACKGROUND
ICH established in 1990 as joint industry/ regulatoryproject to improve through harmonization the efficiencyof the process for developing and registering newmedicinal products
The Fourth International Conference on Harmonization(ICH 4), Brussels, 1997 marks the completion of thefirst phase
It was agreed that the second phase of harmonizationcontinue to ensure the future activities of ICH

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