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6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada
Event Details
Time: October 7, 2020 from 8am to 2pm
Location: Online event
Street: Online event
City/Town: Fremont
Website or Map: https://www.gcplearning.com/v…
Phone: 8004479407
Event Type: online, event
Organized By: John Robinson
Latest Activity: Sep 16, 2020
Event Description
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.
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