JD Supra

eCTD Format Required for all Mutual Recognition Procedure Submissions

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 ...
Yahoo Finance

FDA eCTD (Electronic Common Technical Document) Fundamentals and Process Submissions Course (ON-DEMAND)

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 ...
Business Insider

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: In-Depth Review of the Content and Format Requirement - San Francisco, CA, United States - November 14-15, 2019

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 ...
PharmTech

eCTD now mandatory for the Centralized Procedure

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) ...
Business Wire

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Newark, NJ, United States - November 8th-9th, 2018) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble ...
The National Law Review

FDA Permanently Exempts Type III DMFs for Drug Packaging Materials from eCTD Format Requirement

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Business Wire

Two Day Workshop - eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM) (Philadelphia, PA, United States - November 2-3, 2017) - Research and Markets

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)" conference to their offering. The international ...
GEN

Navigating Electronic Submission Pathways

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 ...
RAPS

Health Canada Finalizes eCTD Guidance

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers ...
Finanznachrichten

2-Day Workshop by Ex-FDA Official: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada - Orlando, FL, United States - February 1st-2nd, 2018

The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official" conference has been added to Research and Markets' offering. The international agreement to ...
PharmaTimes

EMEA draws parameters for electronic-only submissions

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 ...