eRegulatory Submissions Summit


The eRegulatory Submissions Summit will showcase the electronic submission process and protocols for IDMP, RIM, global and regulatory submissions. Regulatory submissions are a key component of the final stages of clinical research and must be properly managed and documented. Attendees will explore information on document management, regulatory requirements, and approaches to managing global and regulatory submissions.

The following topics will be addressed at the eRegulatory Submissions Summit:

  • Methods for overcoming challenges to deliver a successful electronic submission
  • Experiences with eCTD in other countries
  • Obstacles submitters encounter during the preparation, filing and management of regulatory submissions
  • eCTD guidance and requirements
  • Lessons learned from a regulatory operations perspective
  • The requirements and latest developments of the ISO IDMP standards

Click here to see the full agenda


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Camille Venturina

28 April, 2017