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Moscow Marriott Grand Hotel

Oct 23, 2019 8:00 AM - Oct 23, 2019 6:00 PM

Tverskaya street , Moscow, Russian Federation, 26/1

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.

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

Featured

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

Highlights & Features

Learn more

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 Global Head International Regulatory Policy
    Roche, 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
    Critical Path Institute, United States
  • Inka Heikkinen, MBA, MS, MSc
    Inka Heikkinen, MBA, MS, MSc Director, Global Regulatory Policy
    MSD, Denmark
  • Petra Doerr, PharmD, RPh
    Petra Doerr, PharmD, RPh Director
    European Directorate for the Quality of Medicines and Healthcare (EDQM), France
  • Alastair Nixon
    Alastair Nixon Director, Submission Publishing
    GSK, United Kingdom
  • Karl-Heinz Loebel
    Karl-Heinz Loebel Director, Principle Consultant Regulatory Operations
    PharmaLex GmbH, Germany
  • Hans van Bruggen, MSc
    Hans van Bruggen, MSc CSO
    Qdossier, a Celegence Company, Netherlands
  • Marloes van der Geer, MS
    Marloes van der Geer, MS Regulatory Affairs Scientist
    Qdossier, A Celegence Company, Netherlands

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