Update of the e-Roadmap within the EU

June 12, 2018 10:00–11:00 Eastern Time (US & Canada)

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;
- eASMF;
- SPOR Referentials Management System;
- GDPR General Data Protection Regulation.

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