DIA Eurasia Workshop – Implementing eCTD and ICH in the Region

Get first-hand information about the most relevant topics concerning the pharmaceutical industry and top regulators in Russia, Kazakhstan and Belarus, accompanied by learnings from international (former) regulators and key opinion leaders.

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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

Qdossier, a Celegence Company, Netherlands

CSO

Panelist

Dmitriy Rozdestvensky, MD, PhD

Eurasian Economic Commission, Russian Federation

Head, Division for Coordination of Common Market for Drugs and Medical Devices F

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DIA Eurasia Workshop – Implementing eCTD and ICH in the Region

Session 2: Technical Discussion on eCTD

Session Chair(s)

Alastair Nixon

Speaker(s)

Comparison of eCTD and CTD and Preparing your Company for Electronic Submission –Required Business Process Changes

Case Studies on eCTD Review and validation and on eCTD Lifecycle Management

Case Studies on eCTD Review and validation and on eCTD Lifecycle Management

Panelist

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