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) ...

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, 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 ...

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 ...

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 ...

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--(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 ...

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 ...

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...

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 ...