eRegulatory Submissions Summit – eRegulatory Submissions Summit

Regulatory submissions are critical in clinical research and it’s important that regulatory professionals properly manage submissions. The regulatory submissions process can quickly become challenging when multiple team members are involved, and it is essential to ensure the quality and consistency of each document included in a submission. Doing so from the earliest stages of a product’s development benefits your organization.

The eRegulatory Submissions Summit will cover 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 proposed new standards for the identification of medicinal products. Come hear the latest guidelines on eCTD and how to successfully submit an electronic submission.


Featured Speakers

Top Five Reasons to Attend

  1. Understand the challenges that submitters encounter during the preparation, filing, and management of regulatory submissions
  2. Explore the latest developments in ISO IDMP standards
  3. Learn best practices for delivering a successful electronic submission
  4. Discuss global eCTD management and requirements
  5. Navigate the end-to-end process of document and submission management

Who Should Attend

This conference is specifically designed for pharma, biotech and med device professionals responsible for:

  • Regulatory Affairs
  • Regulatory Writing/Medical Writing/Publishing/Information/Submissions
  • Document and eRecords Management
  • IDMP
  • Business Operations/Processing
  • Labeling
  • Clinical Trials Management/Data
  • Clinical Data
  • Outsourcing/Clinical Outsourcing/Vendor Management
  • Product Development
  • Quality Assurance/Quality Control

This event is also of interest to:

  • CROs
  • Regulatory Specialists
  • Regulatory Publishing/Regulatory Submission Software Designers
Startdate: 2017-07-10
End Date 2017-07-11

Description: Coming in July 2017, the eRegulatory Submissions Summit will showcase electronic submissions protocols for IDMP, RIMS, global and regulatory submissions.
Performer: ExL Events
Address : 3549 Chestnut Street eRegulatory Submissions Summit