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6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

November 16 @ 8:00 am - 2:00 pm CST

$545.00

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.

 

https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-ectd-submissions-of-ind-nda-to-the-us-fda,-eu-and-canada-11553LIVE

Organizer

Globalcompliancepanel
Phone:
800-447-9407
Email:
support@globalcompliancepanel.com
Website:
https://www.globalcompliancepanel.com

Venue

Online
Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
+ Google Map
Phone:
7172088666
Website:
https://www.compliancekey.us/webinarDetails?industryId=7&webinarid=1596&speakerid=252&source=EI_LN