Global eCTD - electronic Dossier & eSubmission

Topics

  • eSubmission around the globe
  • Electronic marketing authorisation dossiers for LATAM, ASIA, Middle East and Africa
  • eCTD differences within the ICH region
  • Best practice for global regulatory operations
  • The status quo of the next major eCTD version: version 4.0

Aims and objectives

The electronic submission of marketing authorisation dossiers is not restricted to the ICH region. This seminar will address peculiarities in developing and submitting an eCTD within the ICH region as well as in worldwide eSubmisssion requirements. 
After having attended this seminar, you will be aware of the duties involved in applying for a marketing authorisation in the ICH region and in LATAM, ASIA, Africa and MENA. 
You will know how to improve your regulatory operations work and how to optimise IT support. You will also be well aware of the requirements of the upcoming major eCTD version.

Who should attend?

This seminar addresses the needs of regulatory affairs and medical affairs personnel in the pharmaceutical industry who intend to submit marketing authorisation dossiers within and beyond the ICH region. Prior knowledge of the ICH eCTD concept is required.

Your speakers

  • Maren Müller, EXTEDO GmbH, Ottobrunn, Germany
  • Michael Schaub, ASPHALION S.L., Munich, Germany

Details and registration

Please click here

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