戻る Agenda
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
Roche, Switzerland
Global Head International Regulatory Policy
eCTD implementation: how regional requirements can be aligned, steps for success, industry perspective & learnings from implementation in EU
Alastair Nixon
GSK, United Kingdom
Director, Submission Publishing
Discussion with speakers
Konstantin Koshechkin
FSBI "SCEEMP" of the MoH Russia, Russian Federation
IT Department Head