60 LORENZ Life Sciences News Feed List of all press releases issued by LORENZ. http://www.lorenz.cc <![CDATA[LORENZ Delays Release of eValidator 5.0 to Await Official Adoption of New Specifications; Release Candidate available upon request to docuBridge Customers]]>

Frankfurt/Main, 31st January 2012 // LORENZ Life Sciences Group announced today that it is postponing the release of the new eValidator 5.0 by one month to give regulatory agencies more time to ratify their specifications.

In a meeting with regulatory agency customers it was agreed to delay the official release of the eValidator 5.0 to take into account changes that will be discussed within the EU over the next two weeks, give Health Canada more time to finalize and communicate their new eCTD M1 version 2.1, as well receive more feedback from the FDA in regards to questions on their eCTD validation criteria 2.1.

As a result, the official eValidator version is still version 3.1 SP1 HF2 and will remain so until the above items have been clarified. The release candidate, however, is available upon request for docuBridge and eValidator Professional customers so they can prepare themselves for the new guidelines. The release candidate contains all functionality as well as profiles that may have been finalized but not yet officially adopted by regulatory agencies. To obtain a copy of the release candidate, please contact your account manager.

 

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=164 Tue, 31 Jan 2012 00:01:00 +0000
<![CDATA[LORENZ Life Sciences is working together with the DIA in Europe to offer a “hands-on“ workshop in Barcelona on 8-9 March 2012]]>

Frankfurt/Main, 30th January 2012 // LORENZ announced today the intention to host a workshop in conjunction with the Drug Information Assocation in Barcelona, Spain, on March 8th & 9th 2012. 

During the interactive workshop participants will learn about the Electronic Common Technical Document (eCTD), its components and history, preparing submission ready documents, as well as best practices for changing your business processes in preparation for moving towards electronic submissions. Participants will then apply this information and compile a two-sequence submission for a single country EU national procedure using LORENZ docuBridge®, as well as repurpose the EU compilation for Switzerland.

Key Topics

-  eCTD components and history
-  eCTD vs. non-eCTD electronic Submissions (NeeS)
-  Creating submission ready documents
-  Regional differences in eCTD requirements
-  eCTD compilation
-  eCTD publishing
-  eCTD validation
-  eCTD lifecycle management
-  Regulatory strategy and best practices
-  Co-ordinating global eCTD submissions

Learning Objectives

At the conclusion of this course, participants should be able to:
-  Demonstrate a general understanding of the eCTD
-  Compile a technically validated eCTD for various regions
-  Explain how to maximize the re-use of compiled content
-  Describe the eCTD publishing and technical validation
-  Explain the differences in the regional interpretation of electronic submissions
-  Evaluate the impact of various regional interpretations of eCTD specifications and guidelines on global submissions strategy

Agenda/Registration Form

 

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=163 Mon, 30 Jan 2012 00:01:00 +0000
<![CDATA[LORENZ Pre-Releases eValidator 5.0 / Full Redesign of the World's Most Complete eValidator]]>

Frankfurt/Main, 2nd January 2012 // LORENZ Life Sciences Group is pleased to announce the pre-release of the eValidator 5.0. Apart from a new interface, the new eValidator was completely redesigned from the ground up to incorporate the knowledge gathered from literally thousands of users around the world, including agencies. The pre-release will be submitted to LORENZ' agency customers for review and integration into their environments und will be released to the general public on 31st January 2012.

The new eValidator is based on a proprietary framework that allows LORENZ to quickly adhere to almost any standard around the world. LORENZ has also made some significant visible changes for the end user:

  • The eValidator now uses the same granularity and severity level names as published by the agencies, despite still covering all regions within one product.
  • The validation reports are performed in real-time. This means that the user is able to see the results - and abort if necessary - as the submission is being validated and does not have to wait for the entire validation to be completed.
  • A search function allows the user to search for rules or rule descriptions. A filter further enables users to focus only on certain results.
  • EU, CA US and CH profiles included as standard for eCTD and NeeS, where applicable.

In the professional version, the eValidator is enhanced to provide the following: • Use of multi-core processors in today's computers can improve performance for large submissions significantly.

  • Command line support enables organizations to call the eValidator engine from other systems.
  • A dedicated PowerShell host allows organizations to fully automate validation processes and can be integrated into customer-specific workflow scripts.
  • JP eCTD profile available.
  • Extended EU, CA, US and CH profiles included. These check for criteria that are not officially listed by regulatory agencies but from experience deemed by LORENZ as problem areas in eSubmissions.
  • The professional version includes an enhanced Rule Editor that allows organizations to customize their own rules, even for non-esubmissions. The Rule Editor also now allows entire scripts to be called as part of a validation process.
  • Enhanced and more detailed XML reports allow organizations to perform their own analysis on the results.

As before, the LORENZ eValidator does not only check for the basic XML validity of eSubmissions as many other validators do. The eValidator performs deep-level checks on PDFs, folder structures, bookmarks, hyperlinks and naming conventions as well. The eValidator 5.0 will ship in a basic and professional version. docuBridge users with a current maintenance agreement are eligible to obtain the professional version, as are all users that have licensed the professional version separately. The basic version will be made available for free download on 31st January 2012 on LORENZ' website, http://www.lorenz.cc.

About LORENZ
LORENZ Life Sciences Group is the most established provider of e-regulatory software and services in the world, with the vision to provide the world’s most desirable regulatory solutions. LORENZ has steadily grown its business since 1989, having over 240 customers using e-Regulatory systems in 25 countries. For more information contact us at http://www.lorenz.cc/econtact.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=161 Tue, 03 Jan 2012 00:01:00 +0000
<![CDATA[LORENZ Life Sciences Group celebrates first joint customer with SOLABS as they announce their new partnership]]>

Philadelphia, PA / USA November 30th 2011 // LORENZ Life Sciences Group, the leading innovator for e-Regulatory solutions globally, is happy to announce a new partnership with SOLABS, a top provider of enterprise Quality Management Software to automate quality operations, as well as provide critical compliance to 21 CFR part 11 requirements.

“We have just installed LORENZ docuBridge 5 at our first joint customer operating in the field of women’s health,” said Yaprak Eisinger, Managing Director for North America at LORENZ, adding that, “The partnership has proven to be valuable to all. The whole process from beginning initial dialogue with the organization to training the users who will be doing submissions lasted a matter of weeks, ultimately allowing them to easily exchange regulatory dossiers regarding its products with agencies worldwide.”

“We see many opportunities for SOLABS and LORENZ to collaborate together in offering complimentary solutions to Life Sciences companies as the integration of our systems allows our clients to move from paper-based to electronic environments both in Regulatory Affairs and Quality Operations fields”, said Ericka Moore, Director of Marketing at SOLABS.

About SOLABS
SOLABS offers an integrated software solution which helps improve Quality operations and processes, and provides critical compliance to 21 CFR Part 11 and other regulatory requirements. The SOLABS solution has proven to be easy to use, operate and maintain. SOLABS has been a market leader in North-America by deploying best in class Quality solutions exclusively to the Life Sciences market for more than 10 years. SOLABS delivers a complete solution including software, services and support in a simple, cost-effective manner. For more information on SOLABS, contact Ericka Moore (info@solabs.com) or 1-877-322-1368 ext. 219.

About LORENZ
LORENZ Life Sciences Group is the most established provider of e-regulatory software and services in the world, with the vision to provide the world’s most desirable regulatory solutions. LORENZ has steadily grown its business since 1989, having over 240 customers using e-Regulatory systems in 25 countries. For more information on LORENZ docuBridge 5, eReview or eValidator products, contact us at http://www.lorenz.cc or 1-866-9LORENZ.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=157 Wed, 30 Nov 2011 00:11:00 +0000
<![CDATA[Von der Philosophie zur Realität des Euro [GERMAN]]]>

Frankfurter Podium der Lorenz Systemhaus-Gruppe am 21. November 2011

- Ein Bericht von Matthias Trautsch, Redakteur der FAZ-

Das überraschendste Statement des Abends kommt von Gertrud Traud. „Wir haben gar keine Euro-Krise“, sagt die Chefvolkswirtin der Helaba Landesbank Hessen-Thüringen. Wie schön, möchte man erleichtert aufseufzen. Denn eine hochangesehene Fachfrau, die über das Thema „Optimale Währungsräume“ promoviert wurde, muss es ja wissen. Aber irgendwas scheint doch faul zu sein an der Einheitswährung. Sonst würden die europäischen Spitzenpolitiker kaum von einem Krisengipfel zum nächsten eilen, sonst würden nicht manche meinen, die Europäische Union stehe kurz vor dem Auseinanderbrechen. Und sonst wäre es auch kaum nötig gewesen, zum ersten Mal ein „Frankfurter Podium“ zu wiederholen.

Doch der Reihe nach: Seit 25 Jahren lädt die Lorenz Systemhaus-Gruppe prominente und kompetente Persönlichkeiten ein, um vor einem großen Kreis von Freunden und Geschäftspartnern über die Themen der Zeit zu diskutieren. 1996 trafen dabei, unter Moderation von Hans D. Barbier, die Wirtschaftswissenschaftler Wilhelm Hankel und Michael Heise sowie der Journalist David Marsh aufeinander. Es ging um die Zukunft der europäischen Gemeinschaftswährung. „Damals haben wir über den Euro philosophiert, heute ist er Realität“, sagte Raoul Lorenz, der die Gäste im Firmengebäude in Frankfurt-Rödelheim begrüßte. Angesichts von Griechenland-Misere und Schuldenkrise sei es nun an der Zeit, die Frage nach der Zukunft des Euro erneut zu stellen.

Hankel und Marsh waren nach 15 Jahren wieder auf dem Podium dabei. Der frühere Bundesfinanzminister Hans Eichel kam hinzu. Und dann konnte die Lorenz-Gruppe zwei Damen fürs Podium gewinnen: Heike Göbel, verantwortliche Redakteurin für Wirtschaftspolitik bei der Frankfurter Allgemeinen Zeitung, als Moderatorin und Dr. Gertrud Traud.


Von links: Raoul-A. Lorenz, Dr. Gertrud Traud, Prof. Dr. Wilhelm Hankel, Heike Göbel, David Marsh, Hans Eichel

Eine Krise will die Helaba-Chefvolkswirtin mit ihrer provokanten Äußerung natürlich nicht leugnen, allerdings sei es keine des Euro. Die Einheitswährung sei nicht schwach, sie sei sogar überbewertet. „Was wir haben, ist eine Staatsschuldenkrise.“ Diese sei entstanden, weil es lange ähnliche Zinssätze für höchst unterschiedliche Volkswirtschaften gegeben habe. Die sich nun auftuenden Renditedifferenzen innerhalb Europas entsprächen hingegen den ökonomischen Realitäten und dürften nicht durch Eurobonds überdeckt werden. Der Anpassungsdruck durch hohe Zinsen sei heilsam, denn sie zwinge die Politik zum Reagieren: „Wir können Italien nicht retten, aber Italien kann sich selbst retten“.

Dass der Euro überleben wird, steht für David Marsh außer Frage – allerdings nicht als Währung von 17 Staaten. Er könne sich eine Kernunion vorstellen von sechs bis zwölf Ländern, „die Deutschland ähnlich sind“. Zu diesem Kreis der „Kompatiblen“ zählt er auch die Schweiz oder Norwegen. Für einen wie Wilhelm Hankel, der schon vor 15 Jahren ein kompromissloser Euro-Gegner war, wäre das freilich kein Ausweg. „Eine kleine Union hätte über kurz oder lang dieselben Probleme“, sagt er. Denn der Grundsatz gelte, dass Währung und Staat zusammengehörten.

Diesem Befund kann sich sogar Euro-Befürworter Hans Eichel anschließen, allerdings könnten die Schlüsse, die beide ziehen, kaum gegensätzlicher sein. Für Hankel gäbe es „ein glücklicheres Europa, wenn jedes Land seine Währung hätte“. Der ehemalige Finanzminister, der 2002 das Euro-Bargeld einführte, präsentiert sich beim Frankfurter Podium dagegen als Verfechter einer weiteren europäischen Integration. Währung und Staat gehörten auch für ihn zusammen – deshalb „wollten wir mit dem Verfassungskonvent den nächsten Schritt gehen“. Doch bekanntlich scheiterte dies an den Plebisziten der Niederländer und Franzosen.

Um aus der Krise zu kommen, müsse rigoros gespart werden – soweit ist sich das Podium einig. Außerdem müssten Impulse für Wachstum gesetzt werden, sagen Eichel und Marsh. Doch was, wenn alles nicht hilft? Diese heikle Frage wirft Raoul Lorenz zum Ende der Diskussion auf. Dann müssten die Staaten ihr Schicksal womöglich selbst in die Hand nehmen, meint er, nötigenfalls mit einer Insolvenz.

Wie geht es also weiter mit dem Euro? In einigen Jahren wissen wir mehr. Vielleicht wird Unternehmensgründer Heinz-Jürgen Lorenz dann noch einmal zur Diskussion bitten. Für die vergangenen 25 Jahre Frankfurter Podium bedankt er sich bei den Teilnehmern, dem Publikum und insbesondere bei jenen, die die Veranstaltung ehrenamtlich organisieren und sich um das Wohl der Gäste kümmern: seinen Mitarbeitern. „Ohne sie würde es das Frankfurter Podium nicht geben“.

Über Lorenz
Seit 1989 ist die LORENZ Life Sciences Gruppe (www.lorenz.cc) führender Lösungsanbieter für die regulatorischen Prozesse der Arzneimittelbranche. LORENZ Software wird von über 200 Kunden in 25 Ländern genutzt, um elektronische Zulassungsprozesse zeit- und kosteneffizient zu gestalten. Mit der höchsten Anzahl publizierter eCTDs für Einreichungen in den USA, Europa und Japan, ist LORENZ Software weltweit führend. Während LORENZ über einen beträchtlichen Stamm von internationalen Großkunden verfügt, so gehören auch viele Mittelständler und regulatorische Behörden (u.a. BfArM, Health Canada, AGES, EDQM) zu den Nutzern von LORENZ-Software. Dies ist möglich, da LORENZ bewusst Lösungen für die unterschiedlichen Bedürfnisse verschiedener Marktteilnehmer bereitstellt.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=160 Tue, 29 Nov 2011 00:11:00 +0000
<![CDATA[Mobile Assistance Around the Cemetery]]>

New Donation by LORENZ Foundation

Frankfurt/Main, 24. November 2011 // It’s green, electrically powered, and called the “Lo-Mo” – a new taxi that senior citizens and handicapped persons can use for free at Frankfurt’s main cemetery. Lo-Mo stands for “Lorenz-Mobile” after the sponsor, the LORENZ Foundation. The car can hold up to six passengers, and is enclosed completely in glass to protect against inclement weather.

The idea for the cemetery taxi came in talks with senior citizens, said Heinz-Jürgen Lorenz, founder and Director of the LORENZ Group in Frankfurt. For the elderly it is very important to visit the graves of their loved ones. “Memory is the only paradise you cannot be expelled from,” said Lorenz. However weak or handicapped individuals often find it difficult to make their way across the cemetery. The Lorenz Foundation helps them.

An electric vehicle has already been in operation at the cemetery for over four years, and is heavily used. However, since it has an open top, it is only suitable for good weather. The newly donated vehicle is fully enclosed and can also carry a folded wheelchair. Both vehicles wait at the cemetery’s main entrance and can also be ordered by calling +49-160-9589-1031.

From left: Doris Sedlacek, Nadine Lorenz, Wendelin Friedel, Heinz-Jürgen Lorenz, Gerd Winter

The donation was also encouraged by District Social Chairperson Doris Sedlacek. She helps other senior citizens cope with the challenges of daily life. She was one of the first to try out the Lorenz-Mobile when it was transferred to the city parks department on Wednesday, 16 November 2011. In the winter the taxis operate in the main cemetery from 9 am to 5 pm, and in the summer from 10 am to 6 pm.

Heinz-Jürgen Lorenz, who handed over the new vehicle together with his daughter Nadine, sees the taxi service as a typical example of the LORENZ Foundation motto: “Good can only come about by doing good.” “The state cannot be expected to do everything,” he said. “Society needs to be involved, especially those who have been fortunate in life, and sometimes great joy can be given with small gifts.”.

  

About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) develops and markets 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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=158 Thu, 24 Nov 2011 00:11:00 +0000
<![CDATA[LORENZ' Response to New EU PV Legislation – Regulation No. 1235/2010 and EVMPD]]>

Frankfurt / Main, 31. October 2011 //  LORENZ customers and business partners have successfully completed the first workshop on the new Requirements of Article 57(2) of Regulation (EC) 726/2004 and its impact on the industry. This marked the start of the LORENZ Special Interest Group for EVMPD – XEVPRM.

One of the hot topics in the regulated market space of drug registration are the Requirements of Article 57(2) of Regulation (EC) 726/2004. Since the EU has mandated the European Medicines Agency (EMA) to build a database for all registered product information witin the European Union, many organizations are discussing and planning how to cope with the challenge to supply relevant data within a very aggressive time schedule. The legislation is effective and mandatory as of 2nd July 2012. A quote from the EMA website reads: “The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorizations.”

With this in mind, a strategic group of LORENZ customers and business collaborators came together on 24th October 2011 at LORENZ Headquarters in Frankfurt, Germany. In this workshop the complexity of the undertaking became clear, and the challenging timelines were reviewed.

“The data model, ease of use and proven track record of supplying a data entry platform will be key for our customers and coworkers”, says Wolfgang Witzel, President of LORENZ Life Sciences Group. “There are several facts that we have to accept. Firstly, the draft specification has only been available since 1st September 2011. Secondly, further guidance is outstanding and questions on the specification still needs to be answered. Thirdly, example messages are outstanding. Fourthly, vocabularies are outstanding. And finally, on the technology side, both the Gateway and EVWeb supplied by EMA are not ready. This is a huge challenge for industry.”

“As a result, LORENZ believes this has to be planned carefully and adapted as the specification and guidance becomes more mature. It also means that any organisation offering a final solution today cannot be providing a serious offer and the buyer will possibly be paying a premium,” Wolfgang Witzel continues.

Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, added, “LORENZ has the track record of being the most innovative provider of quality software and related services for e-regulated processes in the Life Sciences industry. As a result, LORENZ too will look into options in providing a validated product for this important process as well.  The ultimate goal is to comply to the future ISO IDMP standard, recognizing that the XEVPRM is an interim standard.”

Further information about the meeting, progress of work and timelines will be distributed and can be accessed via LORENZ ID as of December 2011.

  

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=156 Mon, 31 Oct 2011 00:10:00 +0000
<![CDATA[LORENZ partners with Regxia Inc as ‘e-architec’ is Launched at 2011 RAPS: The Regulatory Convergence]]>

Frankfurt / Main, 24. October// Regxia, a unique scientific and regulatory consulting firm providing solutions for all phases of a product’s life-cycle announced today the launch of e-architec, a new cloud-based e-submission service to be delivered in partnership with LORENZ Life Sciences Group, the global leading provider of submission management solutions for the Life Sciences industry.

“Regxia has been a long-standing customer and trusted partner for LORENZ, so we are thrilled to be able to support them as they launch e-architec,” said Yaprak Eisinger, Managing Director North America for LORENZ Life Sciences Group. LORENZ docuBridge will provide Regxia’s customers with the ability to view real time and remotely the value Regxia is providing on behalf of their submissions. This will bring the element of transparency to the process of outsourcing many in the industry have been yearning for, allowing us to demonstrate LORENZ’s mission to continue to engineer the World’s Most Desirable e-Regulatory Solutions.

“e-Architec is Regxia’s newest service offering and represents a union of Regxia’s global regulatory expertise with LORENZ’s docuBridge and eValidator, creating an industry standard for e-submissions”, said Betty Cory, President of Regxia. This service gives our clients a valuable alternative to implementing their own e-submission platform. With e-architec, each customer will be able to securely access all their applications, provide review comments and become experienced with the platform. All of this along with on-demand access to Regxia’s innovative and strategic consulting services. For small to mid-size companies e-architec provides all the benefits of electronic regulatory communication with significantly reduced investments in time and Dollars.

e-architec’ will be launched at the 2011 RAPS: The Regulatory Convergence Conference in a session presented by Yaprak Eisinger (LORENZ), Betty Cory (Regxia) and Lori Steinhoff (Regxia) on Tuesday, October 25, 2011 at 12:45pm. For more information, visit LORENZ at booth 419 or call 914.310.0097.

 

About Regxia
Regxia (www.Regxia.com) is a unique scientific and regulatory consulting firm with a primary goal to ensure our clients’ success through the use of innovative approaches which encompass all phases of a products’ life-cycle. Regxia seeks to foster long term relationships based upon trust, reliability and common values. Regxia combines knowledge, experience and insight to deliver a broad range of professional services and innovative solutions focused on each customers’ unique product and corporate goals. PROVEN EXPERIENCE, FRESH THINKING!

 

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, visit www.lorenz.cc or call 1-866 9LORENZ/1-866-286-0051. --

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=155 Mon, 24 Oct 2011 00:10:00 +0000
<![CDATA[LORENZ userBridge.11 Synopsis]]>

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=154 Fri, 30 Sep 2011 00:09:00 +0000
<![CDATA[Reading: Giovanni di Lorenzo reads from his book "Wofür stehst Du?" ]]>

3rd Author´s Reading at LORENZ Life Sciences

Frankfurt / Main, 9 September 2011: "On the Pulse of Time" ("Am Puls der Zeit") was the title of the event hosted by LORENZ Life Sciences for customers and friends. Over 200 guests attended the event at the Frankfurt headquarters to listen to the reading and join the following discussion. Giovanni di Lorenzo, editor-in-chief of German weekly newspaper DIE ZEIT, read from his new book "Wofür stehst Du?" (What is Important to You?).
His book, as the subtitle "Was in unserem Leben wichtig ist - Eine Suche" (What is Important in Our Life - A Search) suggests, focuses on the things that are important in life. And so Lorenzo´s stories revealed anecdotes on moral values, his childhood in Italy, and what it was like to grow up as a foreigner in Germany.

Di Lorenzo wrote this book together with co-author and long-time friend Axel Hacke. "Wofür stehst Du?"is not a catalogue of virtues but a personal inventory of lifestyle and habits. The authors search their own lives for answers to complex topics concerning politics, climate change, justice, migration and foreignness, fear and depression, and sickness and death.

A video stream of the reading is available to users via their LORENZ ID.

 

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=153 Fri, 09 Sep 2011 00:09:00 +0000