Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...
DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" webinar has been added to ResearchAndMarkets.com's offering. This four day webinar series (each day 3 ...
DUBLIN--(BUSINESS WIRE)--The "Filing eCTD Submissions" conference has been added to ResearchAndMarkets.com's offering. The eCTD (electronic Common Technical Document) is now mandatory for submissions ...
An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents ...
Dublin, Oct. 16, 2019 (GLOBE NEWSWIRE) -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. This two day workshop ...
The U.S. Army Medical Research and Materiel Command's Enterprise Information Technology Project Management Office helped the U.S. Army Medical Materiel Development Activity submit its first in-house ...
The eCTD is rapidly moving towards the preferred, and in some cases mandated, electronic submission format world-wide. As of January 1st of this year, FDA mandated the eCTD format for all ...
The European Medicines Agency (EMEA) has set a timetable for the implementation of electronic-only applications for marketing authorisation through the centralised approvals procedure. The European ...
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