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Session 2: Technical Discussion on eCTD
Session Chair(s)
Alastair Nixon
Director, Submission Publishing
GSK, United Kingdom
TECHNICAL DISCUSSION ON eCTD Moderator:
Speaker(s)
Comparison of eCTD and CTD and Preparing your Company for Electronic Submission –Required Business Process Changes
Karl-Heinz Loebel
PharmaLex GmbH, Germany
Director, Principle Consultant Regulatory Operations
Case Studies on eCTD Review and validation and on eCTD Lifecycle Management
Marloes van der Geer, MS
Qdossier, A Celegence Company, Netherlands
Regulatory Affairs Scientist
Case Studies on eCTD Review and validation and on eCTD Lifecycle Management
Hans van Bruggen, MSc
Celegence, United States
Director of Regulatory Affairs
Panelist
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F