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 1: The International Environment

Session Chair(s)

Hans van Bruggen, MSc

Director of Regulatory Affairs, Celegence, United States

THE INTERNATIONAL ENVIRONMENT Moderator:

Speaker(s)

Insights into ICH Q12 and impact on future submissions

Susanne Ausborn, PhD

Global Head International Regulatory Policy, Roche, Switzerland

eCTD implementation: how regional requirements can be aligned, steps for success, industry perspective & learnings from implementation in EU

Alastair Nixon

Director, Submission Publishing, GSK, United Kingdom

Discussion with speakers

Konstantin Koshechkin

IT Department Head, FSBI "SCEEMP" of the MoH Russia, Russian Federation

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