3rd eRegulatory Submissions Summit

3rd eRegulatory Submissions Summit

9 July - 10 July, 2019

[email protected]

866-207-6528

https://go.evvnt.com/435355-0?pid=6331

Sonesta Philadelphia Downtown Rittenhouse Square, United States

Organized By:


ExL Events

+1 866-207-6528

[email protected]

http://exlevents.com

494 8th Ave, 4th Floor New York, NY 10001, USA

About 3rd eRegulatory Submissions Summit

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.

Visitors Profile

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

Register ( for this Event )

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