The digitization of regulatory affairs is what the current Lorenz userBridge event is all about, happening from September 23-25th in Milan, Italy. Our PDF Experts at Adlib are currently at the event and engaging with industry experts to share experiences and stories around how customers are using automation to help solve the challenges of meeting regulatory demands.
Live action Lorenz updates
The address from Raoul Lorenz, CEO, was quite an eye opener. This is the 11th annual event, with 170 attendees arriving from 24 countries. An Adlib partner, Lorenz has been growing fast, now with 334 customers in 28 countries since 1998, adding around 3 new customers a month. Their NPS score was a whopping 63% in 2013 – compare that to 29%, the average for the software industry!
The themes of this event are intriguing ones:
Adding value to customers: The FDA is moving towards mandatory electronic submissions, except for academia. The cost of electronic submission vs. paper reduced by over 50% in academia (study by University of Michigan using DocuBridge ONE) as “eCTD ready in under 7 minutes”.
Ensuring interoperability: It is about being to comply to any standard not just astandard.
Improving product performance: DocuBridge 5.4 is over 50% faster for submissions publishing than 5.2.
Working with E2E submissions
In the Bayer E2E eSubmission EU Concept forum, Dr. Barbara Gansewendt spoke on the challenge to move to all electronic submissions worldwide to 200+ agencies. We can either take a centralized or decentralized route. Key factors to consider are urgency, individual company needs, and the balance of global vs. local regulatory agency support options.
EU HQ chose to go with a parent dossier, copying in DocuBridge to the individual country dossier for submission. This way, the end users in the organization can use work streams such as tools, processes, intelligence and training.
Chat with us at Lorenz userBridge
Our own Tieme Stoutjesdijk will be hosting a round table discussion on Populating Your eCTD - Submission Document Rendering. Tieme brings a wealth of knowledge and experience and will provide insightful and relevant discussion around how organizations can improve regulatory compliance processes. Meet up with us at Lorenz userBridge. We’d love to chat with you about improving your document processes.