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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
Director, Principle Consultant Regulatory Operations, PharmaLex GmbH, Germany
Case Studies on eCTD Review and validation and on eCTD Lifecycle Management
Marloes van der Geer, MS
Regulatory Affairs Scientist, Qdossier, A Celegence Company, Netherlands
Case Studies on eCTD Review and validation and on eCTD Lifecycle Management
Hans van Bruggen, MSc
Director of Regulatory Affairs, Celegence, United States
Panelist
Dmitriy Rozdestvensky, MD, PhD
Head, Division for Coordination of Common Market for Drugs and Medical Devices F, Eurasian Economic Commission, Russian Federation
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