The European Medicines Agency informed stakeholders from the pharmaceutical industry about the proposed way forward to progress with the implementation of Article 57(2) of...[more]
The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants...[more]
The European Medicines Agency (EMA) has published a new version of their template for administrative information to be presented in eCTD cover letters within the EU Centralized...[more]
The final version 1.4.1 of the EU eCTD Module 1 specification have been released by EMA. The new version which has the version date "November 2011" incorporates the...[more]
A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes. The new version 1.28 of the Tracking Table contains changes from the...[more]
The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the...[more]
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
