On February 24th, the EMA published the latest version of the EU eSubmission roadmap. Besides the adaption of eCTD 4.0/ RPS timelines, it includes updated CESSP plans with regards to SPOR project implementation plans as well as eCTD timelines for National Procedures. With eCTD becoming mandatory within Europe in the next years, is your organization ready? Are you and your organization prepared for submitting in eCTD format?
EXTEDO and ASPHALION invite you to their Complimentary Webinar "Mandatory Use of eCTD in Europe".
During the webinar, Remco Munnik (Regulatory Information Director, ASPHALION) will talk about update of the EU eSubmission roadmap and how it will impact your organization. Following the theoretical part, Maren Müller (Senior Business Consultant, EXTEDO) will show you the eCTD creation within EXTEDO's eCTD Management Software Solution.
Following the presentation the speakers will answer your questions in the Q&A session.
- EXTEDO Company Overview
- ASPHALION Company Overview
- Explanation of the update EU eSubmission roadmap and impact on companies
- How to get ready for working with eCTD only
- How the mandatory eCTD affects daily operations for industry
- How eAF and CESP will be integrated into CESSP
- eCTDmanager Live Demonstration
- eCTD creation from scratch
- MRP/DCP handling
- Conversion from NeeS to eCTD
- Q&A Session
Event Details and Registration
Date: Thursday, 22 June 2017
- 10:00 am EDT (New York, Philadelphia)
- 03:00 pm BST (London, Lisbon)
- 16:00 h CEST (Madrid, Berlin)
Duration: 60 Minutes
Participation is free of charge.