概览

The Eurasian Union is working to improve the submission process by implementing eCTD and also other ICH guidelines to support the aspiration to increase local manufacturing capacity. As the only public workshop in the region with international experts bringing their knowledge and experience, this is a must-attend for anyone who wants to stay abreast and implement the new requirements smoothly.

Please find registration and logistics information here!

精选主题

Regional eCTD implementation: steps for success
Key ICH guidelines and global harmonization – win-win for all
Experiences from other regions – how to avoid the same challenges?
Centralisation of reviews – learning from Europe

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Want to learn more about DIA Eurasia Workshop – Implementing eCTD and ICH in the Region ? You've come to the right site!

Highlights & Features

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Highlights & Features

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谁应该参加？

Regulatory reviewers and scientific administrators from Eurasian regulatory agencies
Marketing authorization holders in Russia, Kazaksthan and Belarus
Professionals working in regulatory strategy, regulatory policy or regulatory submissions
Professionals involved with eCTD implementation projects

学习目标

Inform about the regional eCTD implementation
Hear and ask directly from the top regional regulators about current and future plans
Learn from the experience from international experts
Exchange and engage with your peers to broaden your professional network

项目委员会

Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland
Elena Popova, DrMed Senior Director Regulatory Affairs & Healthcare Policy
Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation
Tomas Salmonson, DrMed, PhD
Critical Path Institute, Netherlands
Inka Heikkinen, MBA, MSc Regulatory Policy Lead
Lundbeck, Denmark
Petra Doerr, PharmD, RPh Director
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Alastair Nixon Director, Submission Publishing
GSK, United Kingdom
Karl-Heinz Loebel Director, Principle Consultant Regulatory Operations
PharmaLex GmbH, Germany
Hans van Bruggen, MSc Director of Regulatory Affairs
Celegence, United States
Marloes van der Geer, MS Regulatory Affairs Scientist
Qdossier, A Celegence Company, Netherlands