戻る Agenda
SESSION 4 - TRACK A - PREPARING FOR THE FUTURE OF E-SUBMISSION
Session Chair(s)
Andrew Marr, PHD
Managing Director
Marr Consultancy Ltd, United Kingdom
The current ICH and EU specifications for eCTD are well embedded in many organisations and processes for e-submission operationalised. The status quo is not really an option as there are changes are around the corner with the next major version of eCTD and changes to the EU Module 1. Furthermore, process optimisation should be a focus in order to increase efficiency and reduce costs. This session will look how eCTD v4.0, a revised version of EU Module 1 and process optimisation all need to be considered moving ahead.
Speaker(s)
EU Regional Implementation of the eCTD Specification v4.0 – Requirements, Challenges and Advantages
Klaus Menges, DrMed
BfArM, Germany
Project Manager
Change of the eCTD EU Module 1 Specification – Reasoning and Future Options
Mickel Hedemand, MSC
Danish Medicines Agency, Denmark
Special Advisor, Medicines Licensing, Workflow
Optimizing Dossier and Submission Management Process
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations