A24 – eCTD, NeeS and RPS: Worldwide progress in eSubmissions

Already implemented in more than 40 countries, eCTD can in the meanwhile be seen as a worldwide standard for document submissions to health authorities. Several updates of existing M1 specifications as well as new countries joining the eCTD community within the last years ensure a continuous knowledge about electronic submissions ending up in the new standard RPS coming within the next years. This session will give an overview about the progress of eCTD worldwide, best practice experience and a wrap-up of the current status of RPS implementation.

 

Chairperson: Stefan Horneborg, Senior Business Development Manager, Asia Pacific Regulatory Submission Management Solutions, Extedo