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Hotel Holiday Inn

May 23, 2016 7:00 AM - May 25, 2016 5:00 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

16th DIA Conference on European Electronic Data Management and eHealth Topics

The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss how to reduce reliance on paper documents?

SESSION 4 - TRACK A - PREPARING FOR THE FUTURE OF E-SUBMISSION

Session Chair(s)

Andrew  Marr, PhD

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)

Klaus  Menges, DrMed

EU Regional Implementation of the eCTD Specification v4.0 – Requirements, Challenges and Advantages

Klaus Menges, DrMed

BfArM, Germany

Project Manager

Mickel  Hedemand, MSc

Change of the eCTD EU Module 1 Specification – Reasoning and Future Options

Mickel Hedemand, MSc

Danish Medicines Agency, Denmark

Special Advisor, Medicines Licensing, Workflow

Timm  Pauli

Optimizing Dossier and Submission Management Process

Timm Pauli

PharmaLex , United States

Head of Regulatory Operations

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