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Past event: eRegulatory Submissions Summit

Compliantly Navigate the Regulatory Submission Landscape by Examining Regulatory Trends and Challenges for IDMP, RIM, Global and Regulatory Electronic Submissions

The 3rd eRegulatory Submissions Summit examines updates in documentation submissions to regulatory agencies in order to clarify the applications and identify best practices for electronic submissions.

The Regulatory submissions landscape if ever-changing given the obligatory 2018 initiative to make CTD submissions electronic and the 2019 implementation period required for electronic submission of standardized study data. It is essential to ensure the quality and consistency of each document included in a submission to avoid complicating the regulatory submissions process when multiple team members get involved.

The 3rd eRegulatory Submissions Summit will cover changes made to the electronic submission processes and protocols for constructing strategies for IDMP, RIM, global and regulatory submissions. This summit will also address regulatory information management experiences and the standards for the identification of medicinal products and best practices for eCTD submission requirements.

Top Five Reasons to Attend:

  1. Understand the complete regulatory electronic submission process from beginning to end
  2. Assess the latest developments in ISO IDMP standards and understand the future of data in submissions
  3. Review the necessities for EDMS Implementation for eCTD system
  4. Plan improvements to submission processes and ensure communication between all steps in the regulatory submission life cycle
  5. Discuss time to market strategies and the role of submission management, regulatory project management, and agency interactions
  6. Gather the essential information needed to publish eCTD
  7. Explore global and regulatory eCTD management and requirements

Who Should Attend:

This conference is specifically designed for pharma, biotech and med device professionals responsible for:
  • Regulatory Affairs
  • Regulatory Writing/Medical Writing/Technical Writing/Publishing/Information/Submissions
  • Global Submission/Project Management
  • Document and eRecords Management
  • IDMP
  • Business Operations/Processing
  • Labeling
  • Clinical Trials Management
  • Clinical Data
  • Clinical Operations
  • Data Management
  • Outsourcing/Clinical Outsourcing/Vendor Management
  • Product Development
  • Quality Assurance/Control
This event is also of interest to:
  • CROs
  • Regulatory Specialists
  • Regulatory Publishing/Regulatory Submission Software Designers


  • Robert Connelly, Senior Director of Product Management, SYNCHROGENIX
  • Brooke Czapkowski, Global Submissions Manager, PFIZER
  • Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX
  • Sonja Justice, Associate Director, Regulatory Operations, AMICUS THERAPEUTICS
  • Suzanne Libby, Associate Manager, Regulatory Operations, AGIOS PHARMACEUTICALS
  • Lakshmi Ramkumar, Medical Writing Department Head, BOSTON BIOMEDICAL
  • Deborah Satoh, Head of CMC Submissions, TAKEDA
  • Marc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS
  • Robert Stumpo, Director Global Regulatory Medical Writing, TEVA PHARMACEUTICALS
  • Sameer Thapar, Professor, Drug Safety and PV, TEMPLE UNIVERSITY

Please fill in your name and email to receive the Summit Agenda of this event.


Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA


Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St.
Philadelphia, PA 19103

Explore the comfort and fresh, contemporary vibe at the all-new Sonesta Philadelphia. A premier choice among hotels in Philadelphia enjoys spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.

To make reservations, please call 1.800. SONESTA and request the negotiated rate for ExL's July Meetings. To make reservations online Click Here

The group rate is available until June 17, 2019. Please book your room early, as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-20410