Update of the e-Roadmap within the EU
This presentation is an overview of the updates of the e-Roadmap within the EU. It will consist of a mix of eSubmissions, SPOR and GDPR.
The topics included are:
- eCTD for all NPs;
- Brexit for Medicinal Products for human use;
- Policy 0070;
- EU submission portal CESSP;
- SPOR Referentials Management System;
- GDPR General Data Protection Regulation.