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 ...

Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND. Life science companies in today’s shrinking economy are looking for ways to maintain growth in the face of ...

In order to gain further experience with the regulatory enrolment process (REP) and to provide an opportunity for additional sponsors to begin using REP, Health Canada is announcing Stage III of the ...

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 ...

A look into the current state of the eCTD format as well as its future in industry from a global standpoint. From cable to digital, mobile phones to smart phones, dial-up to DSL, cable or wireless—it ...

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, Aug. 29, 2019 /PRNewswire/ -- 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 will ...

This consultation ran from May 7, 2018 to August 10, 2018. Health Canada is considering January 1st, 2019 as the date for mandatory filing of all New Master Files in eCTD format. Feedback for this ...