Simplification and harmonization are the keywords at userBridge.17
Frankfurt/Main, 10 October 2017 // The LORENZ userBridge.17 conference, the annual ‘go-to’ event for the regulatory affairs sector focused strongly on the twin drive for simplification and harmonization. The two-and-a-half-day gathering in Nice, France, was completely sold out 8 weeks in advance, and drew 177 attendees from 22 countries. The format mixed plenary presentations from leading industry and agency figures with ample time for networking and a range of popular table tutorials; small-scale sessions focusing on specific topics.
The gathering kicked off with the unveiling of several new innovations from the host, LORENZ Life Sciences Group: docuBridge TWO, a new version of the company's best-selling eCTD solution that is tailored to small- and mid-sized companies with multiple users; Adam, a new chat-based way to interact with the LORENZ Automator; and a 50-Publishing Token Bundle for docuBridge ONE, which lowers the effective price of publishing a sequence to just €90, a savings of 64%.
The theme of simplification echoed over the three days with presentations from prominent thinkers including Hans van Bruggen of eCTDConsultancy B.V. who urged attendees to “See the unseen: across and within applications”, from Dr. Andreas Franken of BAH, the German Medicines Manufacturers' Association, who touched on the needs for standards and their communication, and from Remco Munnik of Asphalion S.L. on linking IDMP and RIM solutions.
Experiences with the complexities of global e-submissions were covered in depth by a variety of speakers including Philip D. Hall of AbbVie Ltd., Jack Daley from Gilead Sciences Ltd. and Giacomo Ridi of Menarini Ricerche S.p.A.
Agency perspectives were provided by Vianney Caron of Health Canada and Dr. med. Klaus Menges of Germany's BfArM. A separate table tutorial session gave attendees the chance to raise issues with agencies directly, and the agencies present also held a working Agency Day meeting after the conference itself.
Table Tutorials proved particularly popular. Conducted over eight parallel sessions in four different time slots, these small-group sessions included meetings with LORENZ experts on LORENZ products, tutorials on the PSUR Repository, on CESP and the near future changes to CESSP, as well as on EU IDMP SPOR and the Implementation of a Regulatory Information Management Tool.
“The continuing popularity of userBridge is gratifying to see,” said Raoul-A. Lorenz, CEO, “and we think it's because the event strikes the right balance of presentation, discussion and time for networking. We heartily thank all of our presenters and attendees for contributing to yet another remarkable event.”
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 900 paid installations in 35 countries and an average customer growth of 9 customers per month in 2016, LORENZ has a strong worldwide customer base.