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Event Date
Webinar Series - Clinical Trials Guidelines
 Acceptability of Clinical Trial Data in India, China and Asia For Global Marketing Applications
 Location: Singapore
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18 Jul 2013

ICH GCP is considered to be gold standard for the conduct of clinical trials globally. Data from ICH regions: the United States, Europe and Japan, will automatically be accepted as part of a submission for a marketing authorisation in these regions.  Increasingly, data from outside ICH regions, including India, China and Asia are being used to support applications for Marketing Authorisations for Pharmaceutical Products.  This webinar will explore the minimum standards expected by the FDA and EMA for clinical trial data used to support a global MAA in these regions.