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Overview

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!

Featured topics

  • 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

Learning objectives

  • 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

Program Committee

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