eCTD News

Health Canada terminates Non-eCTD Hyprid Pilot phase by end of March 2013 27.04.2012
Health Canada has announced that the Non-eCTD Hybrid Pilot phase will be terminated end of March 2013. The Non-eCTD Hybrid Pilot commenced about two years...[mehr]
[mehr]


Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD and Creation of Canadian Module 1 Backbone 05.04.2012
Health Canada has released a set of new draft guidances together with a new draft verson of their national Module 1 schema version for a 60-day public consultation...[mehr]
[mehr]

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ectdexperts 14.05.2012, 14:50
Irish Medicines Board updates Guide to electronic submissions http://t.co/arCEwGrR #eCTD
ectdexperts 14.05.2012, 11:08
#FDA Guidelines for requesting waiver to current supported clinical study data standard versions http://t.co/PpB5ScL3
ectdexperts 08.05.2012, 10:17
EMA launches also two-week survey to gather information to the future development of their eSubmission website http://t.co/66yijfvh
ectdexperts 08.05.2012, 10:15
EMA launches two-week survey to gather feedback on use of the EudraVigilance website http://t.co/qnh2sXZJ
ectdexperts 30.04.2012, 12:02
EMA requires VNeeS submissions to be 100% compliant to guideline by June 01, 2012 http://t.co/UlxDauoD
ectdexperts 30.04.2012, 11:56
Health Canada terminates Non-eCTD Hyprid Pilot phase by end of March 2013 http://t.co/DzhTvJXj #eCTD
ectdexperts 30.04.2012, 11:31
New XEVMPD controlled vocabularies published by EMA http://t.co/o4THC0qw #XEVMPD; #EVMPD
ectdexperts 05.04.2012, 18:42
The #EVMPD workshops in Dublin and Munich have been a great success - join us in Amsterdam! http://t.co/B35UiInt
ectdexperts 05.04.2012, 18:40
EU CMDh updates guidance documents for the submission of variations http://t.co/i7bQaH7d
ectdexperts 05.04.2012, 18:39
Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD http://t.co/hkn5GAYv