Lorenz Blog

After a two-year break, it was once again time to host one of our face-to-face events – LORENZ Converge. LORENZ Converge was a great opportunity to see old acquaintances as well as many new faces in person! We all learned about the latest developments in the regulatory affairs sector as well as socialized and connected with peers, customers, and colleagues from around the globe.

Speaking of learning and connecting, we of course also enjoyed our other event this year – LORENZ Connect. Introduced as a way to share regulatory affairs topics, valuable insights, tips, and news, LORENZ Connect is now an established online format, drawing almost 400 participants from 32 countries to their screens this year. The participants heard about challenges and successes of leading pharmaceutical companies, current updates on agency projects and specifications, and thoughts on the future evolution of submission management. If you are interested in joining the next LORENZ Connect online conference, then you’re in luck: It’s already just around the corner and is planned for May 16-17, 2023.

 

In addition to that, we offered 36 webinars in the form of free spotlight webinars, What’s New in docuBridge/drugTrack sessions, Online Courses for LORENZ docuBridge, and regional update sessions. We are planning on keeping up with that in 2023 and even improving our offer so that participants have the best possible learning experience. If you don’t want to miss one of our webinars, you should subscribe to our monthly newsletter in which we state all upcoming webinars. Besides our own events, we also took the chance to meet people at other conferences as well, such as RSIDM in North America, DGRA in Bonn, DIA in China, and DIA in Singapore.

Apart from events, many other things happened this year, such as the renaming of our eValidator Enterprise to eValidator FIVE. This was done to streamline our product family and make it more cohesive with our other products. Besides this smaller change we again had two major releases in April and October, which brought many new features and improvements to our software. Besides new features, the releases made sure that our software and in turn you stay compliant and can be rest assured that changes from the agency are implemented ahead of time. When it comes to agencies, we are globally involved in conceptual and technical activities as, for example, with the implementation of eCTD 4.0 functionalities. That’s why we are offering access to a test environment to participate in the pilot phase during the USFDA testing phase for eCTD 4.0.

What’s more, a lot has happened in the context of IDMP, such as a new eAF portal, shifting timelines, and the DADI project. We are eager to keep you informed about these transitions and have also shared a whitepaper on the topic of ‘Dynamic Submission Management (DSM)’ to outline the evolution of change and what opportunities this holds for both industry, health organizations, and technology vendors. To access this whitepaper, please click here.

Last but not least, we were happy to host some internal events, such as a spring and a winter festival, as well as the opening of our freshly renovated office which is praised as one of the “Top 5 office spaces in Frankfurt” and is even a showcase for architects and the real estate industry. Particularly with the freshly renovated office, we reached a milestone as many colleagues are used to working from home, but with the new office more and more colleagues are coming back to work in a nice setting and connecting with other LORENZ members. And what makes this all the more necessary is that we have been fortunate enough to find many professionals who have joined the ranks of LORENZ and are eager to meet their peers in person as well.

We can’t wait to see what next year will bring, and we are sure it will offer many new opportunities. Until then, LORENZ wishes you all happy holidays and a joyful start to the new year.

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