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Interoperability continues to define thinking at userBridge.15 conference

Oct2015
05

Frankfurt/Main, 05 October 2015 // Vienna, Austria was the setting for this year’s userBridge conference, the annual global e-regulatory affairs gathering organized by the LORENZ Life Sciences Group, the world’s premier supplier of eCTDs. This sold-out event attracted over 175 participants from more than 25 countries, and saw a range of personalities from industry and agencies share leading edge thinking in the sector, with interoperability once again emerging as a core topic. As with past conferences, userBridge.15 included a range of small-scale table tutorials, and the overall program was designed to ensure participants plenty of time for networking.

Presentations underline aspects of interoperability
Interoperability, i.e. the ability of different information technology systems and software applications to communicate, exchange data, and actually use that information, is critical for the future of the e-regulatory affairs sector. This was highlighted in the keynote speech by Raoul-A. Lorenz, CEO of the LORENZ Life Sciences Group, and was echoed in a range of presentations.

Insights into the future of regulatory data exchange were offered by Michiel Stam of Qdossier B.V. An IDMP update by Andrew Marr of Marr Consultancy Ltd. & Markus Pfahlert from LORENZ Life Sciences Group was followed directly by a hands-on case study of what needs to be done in a mid-size pharmaceutical company to prepare for IDMP, outlined by Dr. Dieter Schlaps of IT-Consulting Life Sciences.

Deborah Cooper of Genpact Pharmalink Ltd. gave her thoughts on which comes first: Regulatory Information Management or ISO Identification of Medical Products, while Dr. Martin Donsbach of Kohne Pharma GmbH outlined how industry is actually progressing its RIM programs.

Global perspectives
The truly global nature of userBridge.15 was underlined with presentations from around the world including updates on eCTDs from the GCC (KSA & Oman) by Karl-Heinz Loebel of PharmaLex GmbH, and from Brazil by Larissa Engel of Bayer S.A.

The agency perspective was also covered globally with a variety of presentations including an overview of the RPS business case and Health Canada’s roadmap by Denis Mulhall, an IDMP use case from Germany’s BfArM by Dr. med Klaus Menges, and an overview of progress towards eCTD in Thailand by Kritsada Limpananont of the Thai FDA.

Table Tutorials
The morning of day two offered 28 table tutorial sessions and gave participants the chance to cover specific topics in smaller face-to-face discussions and demonstrations. Topics covered varied from the new Change Request Object in LORENZ drugTrack, Africa on the Move, and ASMF Basics, to EU Module 1 and the phasing of IDMP implementation.

“We were thrilled with the quality of presentations and tutorials at userBridge.15 because they covered interoperability from a wide range of perspectives,” notes Raoul-A. Lorenz, CEO of the LORENZ Life Sciences Group, “and we were also gratified by the many positive comments from participants, who appreciated the familiar yet professional atmosphere at the conference.”

Agency Day
Following the main event, agency regulators took the opportunity for an inter-agency meeting. Organized by the German BfArM and hosted by the Austrian regulator (AGES), members from 11 different agencies discussed the challenges and opportunities of automated processing. As an ICH expert and former Electronic Submissions Specialist at the US FDA (CDER), Jared Lantzy of LORENZ was also invited to attend.

  

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's solutions are geared specifically for submission assembly, review, publishing, validation and management. LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With over 500 installations in over 25 countries, LORENZ has a strong worldwide customer base.