How to cut time and cost by re-using already submitted documents. Increasing drug-development costs, patent expirations, and fewer blockbuster drugs in the pipeline are forcing life-science companies ...

All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...

In 2005, the heads of the European medicines agencies agreed that all EU member states must have the infrastructure and processes in place to handle only electronic Common Technical Document (eCTD) ...

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 ...

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 ...

An initial marketing application submission is a major undertaking that requires a large team, numerous tools and a litany of subprocesses to work together in harmony for a successful outcome. Leaving ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

This course will offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on ...

Dublin, Aug. 01, 2023 (GLOBE NEWSWIRE) -- The "Filing eCTD Submissions Training Course" conference has been added to ResearchAndMarkets.com's offering. This intensive one-day course will provide an ...

10545 This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on ...