eRegulatory Submissions Summit – eRegulatory Submissions Summit

Regulatory submissions are critical in clinical research and it’s important that regulatory professionals properly write and handle regulatory submissions. Regulatory affairs professionals need to ensure the safety, quality and efficiency in medicine. This process becomes challenging when it involves multiple team members. Don’t miss out on the opportunity to gather information on document management, regulatory requirements and the management of eCTD submissions.

The eRegulatory Submissions Summit will cover best practices and help attendees understand electronic submissions and protocols for IDMP, RIMS, global and regulatory submissions. Come hear the latest guidelines on eCTD and how to successfully submit an electronic submission.

Top Five Reasons to Attend

  1. Share challenges and techniques for how to deliver a successful electronic submission
  2. Learn best practices for how to manage regulatory information
  3. Understand the recent and latest developments of the ISO IDMP standard
  4. Network with industry leaders in regulatory affairs and operations
  5. Discuss global 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/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