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LORENZ userBridge 2010 - Frankfurt, Germany

Summary

Every year, LORENZ userBridge represents not only a forum for LORENZ customers to learn where LORENZ is heading. It has also become an annual meeting point for those interested in the digitization of regulatory affairs. Whether it is information about new regulatory guidelines, pitfalls with change management or views from regulatory agencies, userBridge is synonymous with education and information exchange on the highest level. And it provides an opportunity for business. LORENZ partners have the ability to make contacts in a relaxing atmosphere, providing ample time to communicate skill sets and key success factors.

Last year, LORENZ looked back at 20 years of e-submissions with LORENZ. This year, LORENZ looks back at 20 corporate years. To mark this event, LORENZ will once again have planned an exciting agenda - including, of course, the very successful table tutorials.

Among its regular attendees, userBridge has become an institution - we hope that you will join this institution as well.

Conference Details

Date: 21st September - 23rd September 2010
Venue: Kempinski Hotel Gravenbruch (Hotel Information)

Click here to obtain a downloadable version of the hotel room reservation form. PLEASE NOTE: LORENZ has obtained a reduced rate for this event.

List of Speakers & Table Tutorial Leaders

To be announced.

Registration Form

Registration is available online. Please click here to go to the registration form.

LORENZ userBridge 2009 - Warsaw, Poland

Trailer

Summary

With 130 attendees from 19 countries, userBridge 2009 was a huge success. Delegates were not only able to learn about new LORENZ products, services and technology trends, but also about RPS, structured authoring, processes for creating parallel eCTD submissions to several regions, the new EU variation guideline, challenges with PDF, as well as status updates from various regulatory agencies and much more.

The table tutorials, a new feature to the userBridge, received overwhelmingly positive feedback, hosting smaller interactive groups discussing STFs, US Module 1, EU Module 1, LORENZ docuBridge V, Document Management & Submission Management Processes, Type 2 Variations, Mutual Recognition Tracking Tables, making maximum use of LORENZ eValidator and much more.

LORENZ would like to thank all attendees for making the conference the success it was. 2009 also marked 20 years of e-Submissions at LORENZ and userBridge was also the venue at which LORENZ was able to announce winning the tender to supply an eCTD review system for the Polish regulatory authority.

If you would like to be part of this educational event, which has value not just for LORENZ customers, the keep your eyes open for more information in this section: the next event will take place in Frankfurt, Main, Germany on September 21 - 23 2010, entitled "Back to the Roots".

Conference Details

Date: 22nd September - 24th September 2009
Venue: Sofitel Victoria

List of Speakers & Table Tutorial Leaders

Prof. Dr. Rolf Bass Pharmaceutical Business Consultant
Scott Mackey Adlib Software
Harald Binder AGES Pharm Med Austria
Dr. Dietmar Böcker Bayer HealthCare AG
Dr. Christian Dinter Bayer HealthCare AG
Markus Segref Bayer Schering Pharma AG
Dr. Klaus Menges BfArM
Steffen Frederiksen Content Technologies ApS
Hiroji Emoto Digital Media System Co., Ltd.
Sven Harmsen e-DRA
Sibylle Teuchmann Exalon GmbH
Karel Bastiaanssen Iperion
David Obranovic JAZMP Slovenia
Dr. Sebastian Knieps LionPharm
Jason Berning LORENZ Life Sciences Group
Kent Briggs LORENZ Life Sciences Group
Joshua Johnson LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Charles Mathis LORENZ Life Sciences Group
Akira Yamaguchi LORENZ Life Sciences Group
Andreas Zapf LORENZ Life Sciences Group
Elke Klein NDA Regulatory Service GmbH
Inge Neubauer NDA Regulatory Service GmbH
Dr. Karl-Heinz Löbel Pharmalex GmbH
Marciej Piwowarski Polpharma SA
Betty Cory Regxia Canada
Lori Steinhoff Regxia Canada

Download Agenda (PDF)

Download Table Tutorials (PDF)

LORENZ userBridge 2008 - Lisbon, Portugal

Trailer

Summary

LORENZ has successfully concluded its 6th LORENZ user conference, userBridge 2008. The conference was held at the Sheraton in Lisbon and included delegates from all over the world, from industry, as well as from regulatory agencies.

Over the two-and-a-half days, delegates were able to witness some of the dramatic improvements of docuBridge 5.0, the world’s leading submission management system, as well as some additions to the drugTrack submission tracking software. Some 23 presentations were held, 20 of which were held by customers from both industry and agency. These presentations focused on regulatory guidelines and changes, experiences with agencies as well as additional usage of the docuBridge system within existing environments.

A further highlight of the event was the first Inter-Agency docuBridge User Conference, at which four regulatory agencies participated. Topics discussed included current strategies at the agencies, as well as additional functionality and requirements for reviewing purposes.

Conference Details

Date: 23rd September - 25th September 2008
Venue: Sheraton Lisboa Hotel & Spa

List of Speakers

Peter Duff Adlib Software
Hans van Reeuwijk Astellas Pharma Europe
Franz Schuller AGES Pharm Med Austria
Dr. Klaus Menges BfArM
Yasuo Takeuchi Chugai Pharmaceutical
Dr. Arnold P. J. van der Marel Disphar International
Antoinette Azevedo e-SubmissionsSolutions.com
Erik Thygesen Ferring Pharmaceuticals
Dr. Hannes Perschinka Gebro Pharma
Dr. Jörg Lautz Grünenthal
Glenn Austin Health Canada
Vianney Caron Health Canada
Karel Bastiaanssen Iperion
Dr. Martin Moxham i-Regulatory
Dr. Sebastian Knieps LionPharm
Akira Yamaguchi LORENZ Life Sciences Group
Charles Mathis LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Dr. Oliver Denk PARI Pharma
Gina Galligani Pronova BioPharm Norge
Jeff Wilson Submission Consulting Group
Dr. Albert Edwards Takeda Global Research & Development Center
Dr. Stefanie Frank YES Pharmaceutical Development Services

Download Agenda (PDF)

LORENZ userBridge 2007 - Nice, France

Trailer

Summary

The LORENZ Life Sciences Group held their 5th Annual Conference during September in Nice, France, and had a turnout that far exceeded its expectations. 18 countries were represented by approximately 150 attendees, with a large contingent coming all the way from Japan.

With speakers from both the authorities and industry from Europe, North America and Asia, topics presented ranged from the current electronic initiatives at the various health authorities, the latest eCTD 3.3.3 update, PIM, and various case studies on the benefits of moving to electronic publishing. Those attending not only had the opportunity to network with each other during the event but also at the formal dinner event at "Le Château du Domaine St.Martin".

"The attendance level at this year’s event was more than we could have hoped for," said Wolfgang Witzel, President of LORENZ. "Bringing together this many people from so many countries for one purpose, to share and learn how others are working in today’s regulatory arena, is very important. Not only is LORENZ able to learn more about the needs and requirements of those attending the event and the regulatory branch in general, but we are also able to provide all attendees an ideal setting for networking and learning from each other. The feedback from everyone was very positive and we hope we will be able to achieve the same success next year."

A particular highlight was the presentation of the LORENZ docuBridge V (5.0) concept, an all new development.

Conference Details

Date: 18th September - 20th September 2007
Venue: Boscolo Hotel Plaza

List of Speakers

Caroline Auriche AFSSAPS France
Franz Schuller AGES Pharm Med Austria
Sven Harmsen Astellas Pharma
Dr. Dietmar Böcker Bayer Healthcare
Prof. Dr. Rolf Bass Berlin, Chemie
Robert Scharinger BMFG, Austria
Hiroji Emoto Digital Media System
Sonja Krisam Dr. Regenold
Dr. Alexander Kainz Fresenius-Biotech
Dr. Philipp Birch Fulcrum Pharma
Denise Oliveira Genzyme Corporation USA
Raun Kupiec Genzyme Europe
Dr. Sebastian Knieps LionPharm
Akira Yamaguchi LORENZ Life Sciences Group
Charles Mathis LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Karin Gröndahl MPA Sweden
Jörg Schnitzler Merck Serono
Dr. Maren von Fritschen Pharmalex
Päivi Jeronen Santen
Lois Householder TAP Pharmaceutical Products
Prof. Dr. Schweim University of Bonn

Download Agenda (PDF)

LORENZ userBridge 2006 - Berlin, Germany

Summary

The annual user conference 2006 was held in the dynamic city of Berlin, Germany. As always, we brought together speakers from both industry and health authorities, giving the opportunity to not only obtain the latest information on certain topics but to discuss and share information with peers on current issues and hot topics impacting Regulatory Affairs.

LORENZ presented a new customer, the Canadian Authority. Vianney Caron, from Health Canada, spoke about their experiences with docuBridge® and the perspective on eCTD Life Cycle Management. This laid the groundwork that led to many interesting discussions during the conference.

Conference Details

Date: 12th September - 14th September 2006
Venue: Steigenberger Hotel Berlin

List of Speakers

Caroline Auriche AFSSAPS France
Sven Harmsen Astellas Pharma
Hiroji Emoto Digital Media System
Sonja Krisam Dr. Regenold
Antoinette Azevedo e-SubmissionsSolutions.com
Dr. Andre Dorochevsky Fresenius-Biotech
Vianney Caron Health Canada
Jeremy Nutall International Partnership for Microbicides (IPM)
Dr. Sebastian Knieps LionPharm
Akira Yamaguchi LORENZ Life Sciences Group
Charles Mathis LORENZ Life Sciences Group
Dr. Olaf Schoepke LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Rainer Albert Medigene
Karin Gröndahl MPA Sweden
Dr. Maren von Fritschen Pharmalex
David Cornwell PleaseTech
Andreas Zapf STADA Arzneimittel
Dr. Albert Edwards TAP Pharmaceutical Products

Download Agenda (PDF)

LORENZ userBridge 2005 - Vienna, Austria

Trailer

Summary

The 3rd Conference has taken place in Vienna, Austria. Wolfgang Witzel, President of LORENZ Life Sciences Group said the success of this event is in part due the coming together of users from both sides: the authorities and the worldwide users of docuBridge®.

Of major interest was the live product presentation of labelBridge and drugTrack. A further highlight of the event was the presentation of the experiences using eCTD in Japan from our partner Digital Media Systems as well as the dissertation from Dr. Klaus Menges from BfArM, the German authority.

Conference Details

Date: 14th September - 15th September 2005
Venue: Grand Hotel Wien

List of Speakers

Konrad Moser Adobe Systems
Queenia Lee Apotex
Lothar Höniger Berlin Chemie
Dr. Klaus Menges BfArM
Robert Scharinger BMGF Austria
Hiroji Emoto Digital Media System
Dr. Jürgen Regenold Dr. Regenold
Dr. Alexander Kainz Fresenius-Biotech
Denise Oliveira Genzyme Corporation USA
Dr. Kurt Eisinger Igeneon
David Cornwell KCentrix Software
Dr. Sebastian Knieps LionPharm Consulting
Akira Yamaguchi LORENZ Life Sciences Group
Andreas Zapf LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Charles Mathis LORENZ Newbook
Dr. Matthias Zimmermann Merz Pharmaceuticals
Dr. Chieu Diep NOMA Norway
Michael Abernathy QLT USA
Dr. Marco Lange SAP Life Sciences
Dr. Albert Edwards TAP Pharmaceutical Products
Andrew Marshall Virtual Regulatory Services
Dr. Jürgen Hönig YES Pharmaceutical Services

Download Agenda (PDF)

LORENZ userBridge 2004 - Munich, Germany

Trailer

Summary

The second international user conference of our state-of-the-art submission management system docuBridge® has taken place in Munich, Germany. The conference covered compliance, business, process and technology over two days. Users from industries and authorities presented their experiences with docuBridge®. LORENZ also announced their new as well as improved add on products for PDF rendition and submission tracking

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Conference Details

Date: 14th September - 15th September 2004
Venue: Kempinski Vier Jahreszeiten

List of Speakers

Pedrag Denkovski Apotex
Dr. Marko Vitas ARSZMP Slovenia
Dr. Lothar Höniger Berlin Chemie
Dr. Klaus Menges BfArM
Hiroji Emoto Digital Media System
Stephan Montag Dr. Falk
Sven Harmsen Fujisawa
Dr. Heinrich Hambloch GITP
Akira Yamaguchi LORENZ Life Sciences Group
Alexander Stapf LORENZ Life Sciences Group
Dr. Olaf Schoepke LORENZ Life Sciences Group
Kent Briggs LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Charles Mathis Newbook
Dr. Jürgen Regenold Regulanet

Download Agenda (PDF)

LORENZ userBridge 2003 - Frankfurt, Germany

Trailer

Summary

The inaugural worldwide user conference, this event was held close to the LORENZ HQ in Frankfurt, Germany. The event was attended by 65 delegates from eight different countries. The focus of the userBridge conference was on education rather than marketing and this proved to be a huge success.

The focus was to learn, discuss and interact with users from industry and authorities alike. The two-day event was an ideal platform to understand how your peers were implementing docuBridge. An overview of the growing product suite was given and additional solutions were presented to docuBridge users. Further information included updates on ICH, FDA, EMEA and MHLW.

Conference Details

Date: 23rd September - 24th September 2003
Venue: Steigenberger Frankfurter Hof

List of Speakers

Dr. Andreas Petermann 3M ESPE
André Koppany Adobe Systems
Dr. Lars Johannsen Bayer
Dr. Volker Geiss Bayer
Lothar Höniger Berlin Chemie
Dr. Klaus Menges BfArM
Marcel Mössner Comprendium
Ralph Geiger Documentum
Dr. Jörg Lekschas Federal Institute for Drugs and Medical Devices
Ulrich Kunz Federal Institute for Drugs and Medical Devices
Sven Harmsen Fujisawa
Dr. Heinrich Hambloch GITP
Dr. Sebastian Knieps LionPharm
Akira Yamaguchi LORENZ Life Sciences Group
Dr. Detlev Rhäsa LORENZ Life Sciences Group
Raoul-A. Lorenz LORENZ Life Sciences Group
Dr. Oliver Denk Scil Biomdedials
Dr. Andreja Orazem Slovenien Agency
Stephen Kern SNBL

Download Agenda (PDF)

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