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!
- 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
Who should attend?
- 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
- 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
Susanne Ausborn, PhD • Regulatory Policy Lead
F. Hoffmann-La Roche Ltd, Switzerland
Elena Popova, DrMed • Senior Director Regulatory Affairs & Healthcare Policy
Association of International Pharmaceutical Manufacturers (AIPM), Russian Federation
Tomas Salmonson, DrMed, PhD • Partner
Consilium Salmonson and Hemmings, Sweden
Inkatuuli Heikkinen, MSc •
Petra Doerr, PharmD, RPh • Director/Owner
Petra Dörr Consulting GmbH/Ltd., Switzerland
Alastair Nixon • Director, Submission Publishing
GlaxoSmithKline, United Kingdom
Karl-Heinz Loebel • Director, Principle Consultant Regulatory Operations
PharmaLex GmbH, Germany
Hans van Bruggen, MSc •
IRISS Forum, Netherlands
Marloes van der Geer, MS • Regulatory Affairs Scientist