eCTD Content and Format
WebcastFaculty
OVERVIEW
eCTD Content and Format is organized by International Pharmaceutical Academy (IPA) and would be held during on Mar 09, 2017.
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 eCTD has increased efficiency for reviewers and improved submission times.This webinar will provide you with a review of the content and format requirements of the eCTD.
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 eCTD has increased efficiency for reviewers and improved submission times.This webinar will provide you with a review of the content and format requirements of the eCTD.
SPECIALITIES
Pharmacy and MedicineQuality Management
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