Category Archives: LORENZlink News

Want to learn about new US Module 1 specifications? – Visit LORENZlink 2016 in April!

With the release of version 3.3 of its eCTD Module 1 specifications, the US FDA has enabled industry to streamline eSubmission processes. With these new features come added complexity that must be mastered to take full advantage of upgraded functionality. Join us at the inaugural LORENZlink RIM conference on April 4 – 5, 2016 in Scottsdale, AZ, for a detailed discussion of changes and lessons learned to ensure a successful transition to the new Module 1. You will learn about:

  • FDA experience with the new Module 1 including common validation errors
  • Considerations and best practices for transition
  • When and why grouped submissions make sense
  • Tips for preparing and submitting Promotional Labeling and Advertising in eCTD format
  • Updates on US FDA’s upcoming eCTD mandate

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