Clinical Trial Applications in eCTD format (available upon request) Guidance Document - Preparation of Regulatory Activities in Non-eCTD Formats; 2.2.4 Guidance on the QOS-B (Schedule D drugs) The ...

The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

Performing quality checks on the eCTD Updating content in the CTD and eCTD (amendments, supplements, variations, etc.) For more information about this webinar visit https://www.researchandmarkets ...

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 ...

The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

The European Medicines Agency issued a reminder about the Jan. 1, 2010 deadline for e-CTD submissions. The European Medicines Agency (EMEA) has issued a reminder that the electronic Common Technical ...

DUBLIN, Sept. 17, 2018 /PRNewswire/ --The 'eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada' conference has been added to Research ...