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.
Our annual community conference LORENZ userBridge is well-known for showcasing the very latest thinking from the world of regulatory affairs, with high-level speakers recruited to give a wide range of expert perspectives from industry, agencies and consultants.
A variety of agency and industry players will be sharing their experiences at userBridge.17. Please see the preliminary agenda for more details.
We look forward to welcoming you to Nice!
LORENZ userBridge, our annual LORENZ community conference, is one of the most educational events in e-regulatory affairs globally, bringing together both industry and agency perspectives in one gathering.
Would you like to get a vivid impression of our conference? Watch the LORENZ userBridge Video!
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
We’re looking forward to seeing you in Vienna next week at userBridge.15. The conference is completely sold out.
The team here has packed up all our material and is ready for the trip to Austria. All conference participants can look forward to three days of learning, discussion and interacting with people from industry and agencies. We wish you an interesting, successful and simply great userBridge.15!
Over more than a decade, the LORENZ userBridge Conference has grown to become THE conference for learning all about current e-regulatory affairs. Speakers are recruited from the highest levels of the regulatory affairs world, and topics are selected for their timeliness and relevance to our customers. This year you’ll find IDMP, RIM, and process optimization all on the agenda, as well as the status of eCTD in different countries around the world, and a wide range of other current issues.