UPDATE: LORENZ regretfully cancels LORENZlink 2020. Click here to read more.
The LORENZlink 2020 RIM conference is taking place from April 21-22, 2020 in Vancouver, Canada.
Our two-day conference will feature presentations and tutorials by many distinguished LORENZ customers, partners and employees. The agenda includes a range of hot topics from prominent experts. See some highlighted topics below or the whole agenda by clicking here.
After the two-day conference, you can join us for the the optional day (April 23, 2020) of docuBridge training!
Register here for the conference or here for the training day.
When eCTD was introduced more than a decade ago, the implementation of a new Submission Management Solution (SMS) was primarily a technical challenge and an adventure. Tool vendors were focused on creating submissions using documents from Document Management Solution(s) (DMS) and then publishing eCTD sequences compliant with agency specifications. From a process perspective, this was a new clean step without technical connections to the legacy – either paper or electronic submission of other formats. Project work on legacy submission migration was not needed.
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