HEALTHCARE TRAINING 2021 - 6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada
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Website https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-ectd-submissions-of-ind-nda-to |
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Category HEALTHCARE TRAINING 2021
Deadline: May 28, 2021 | Date: May 28, 2021
Venue/Country: Online event, U.S.A
Updated: 2021-04-30 20:22:12 (GMT+9)
Call For Papers - CFP
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.Why you should attendThis webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. Who Will BenefitRegulatory AffairsQuality AssurancePharmacovigilanceProject ManagementRegulatory OperationsAnyone responsible for providing content for the CTD
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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