Frankfurt / Main, 30. September 2011 // ”Learn – discuss – interact” is a long standing LORENZ user conference motto. Presentations and workshops (to learn) as well as the eRegulatory Forum (to discuss) and table tutorials (to interact) have traditionally been used at LORENZ in order to provide insight, new techniques and best practices when it comes to e-Regulatory Affairs. LORENZ’s international user conference, userBridge, held this year in Turin, Italy, enjoyed over 140 attendees from 23 countries. For several years now, the LORENZ userBridge conference has been chosen by Regulatory Affairs professionals as a primary venue for being immersed in new developments and topics in eRegulatory Affairs.
The opening speech was held by CEO Raoul-A. Lorenz, who introduced several new releases and drew special attention to advantages of LORENZ ID, a gateway to the LORENZ ecosystem with access to training certificates, news, software update notifications, live video streams and more.
eRegulatory Forum panelists discussed the concept of Foreign Review
This year, the eRegulatory Forum panel discussion was moderated by Dr. Christine Mayer-Nicolai (Head Regulatory Coordination Europe & Global Regulatory Intelligence, Merck Serono). Three highly respected panelists, Dr. Supriya Sharma (Director General, Therapeutic Product Directorate, Health Canada), Dr. Birka Lehmann from BfArM, and Fiona McLeod (European Directorate for the Quality of Medicines & HealthCare, EDQM) discussed the current state and challenges of the idea of Foreign Review used by various agencies across the world today. Amongst some of the interesting discussion points were why health agencies need to collaborate with each other, why there is a need for them to stay sovereign and how to balance these demands so that life saving drugs will reach the end users in a safe and timely manner.
Speeches, Table Tutorials and LORENZ clubs
20 speakers presented at this year’s userBridge conference - only three of them were LORENZ employees; the rest were LORENZ customers and partners sharing their knowledge. “It was my first time at userBridge and I was very impressed. This conference is more than a kind of a company’s showroom – it’s really providing high quality educational content”, said Kathie Clark, expert in content management for the pharmaceutical industry working at NextDocs and one of the speakers at this year’s conference.
14 table tutorials, a concept first introduced in 2009, were once again a resounding success allowing smaller groups of professionals to exchange information and learn more interactively. Topics included ‘Effective Outsourcing of e-Submissions’, ‘Advanced Reporting in drugTrack’, ‘New Validation Criteria’ and much more.
Finally, the number of e-Submissions at LORENZ increased once again. The LORENZ 1K club, paying tribute to docuBridge customers that have passed the 1,000 submission mark, currently holds 12 members. Likewise, the 5K club marks the 5,000 e-submission mark and has three members.
Conference Extension for Health Agencies
userBridge 2011 was extended by another one and a half days offered especially to delegates of Health Agencies. Eight agencies attended the interactive sessions, exchanged the latest status of their review processes, numbers of incoming submissions/dossiers and future plans. Extending userBridge for members of Health Agencies to facilitate information exchange will now be an ongoing element of LORENZ’s user conference.
See you again in Dublin next September!
The whole event provided an exchange platform for delegates from both industry and national health authorities to discuss changing requirements and technological advances,“ said Raoul-A Lorenz, and added: “We learned much about many topics from pharmacovigilance, AMNOG, baseline submissions and FDA sponsor meetings. We also learned about best practices in many areas. As always we strive to make this an educational event, not a marketing event, and we hope we have achieved that.”
Next year, userBridge will take place from 25th– 27th September 2012 in Dublin, Ireland.
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. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 200 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.
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