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 "Filing eCTD Submissions" conference has been added to ResearchAndMarkets.com's offering. The eCTD (electronic Common Technical Document) is now mandatory for submissions ...

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, 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 ...

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 ...

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 ...

EMC this week announced Document Submissions Manager for electronic common technical document (eCTD) software, designed to simplify the management, assembly, and delivery of drug applications to ...

Full Suite of Products and Services Navigate Evergreen Regulatory Environment Whippany, NJ - September 3, 2010 - Last year, the pharmaceutical industry in the Association of Southeast Asian Nations ...

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 ...

Full Suite of Products and Services Navigate Evergreen Regulatory Environment Whippany, NJ - September 3, 2010 - Last year, the pharmaceutical industry in the Association of Southeast Asian Nations ...