LORENZ Life Sciences News Feed

Pharma to Market and LORENZ Life Sciences announce Australia-New Zealand partnership

Tue, 28 May 2013 00:05:00 +0000

Brisbane, Australia and Frankfurt am Main, Germany Thursday, 28 May 2013 // Pharma To Market, a leading Australian based service provider for pharmaceutical companies and LORENZ Life Sciences Group, the world’s preeminent supplier of e-Regulatory solutions, jointly announced a strategic partnership today. This new agreement paves the way for Pharma To Market to offer LORENZ solutions in Australia and New Zealand, as part of their wider range of outsourcing services for eCTD, NeeS and paper publishing to companies in the region.

The partnership opens up the Australian and New Zealand markets for LORENZ products and related services. The Therapeutic Goods Administration (TGA), the Australian health authority and industry are currently preparing to implement eCTD solutions, so this partnership announcement is well-timed.

"The electronic submissions market is growing quickly in many regions," says Wolfgang Witzel, President of LORENZ Life Sciences Group, "and we believe Australia will become a thriving area for us. We are delighted to have Pharma To Market representing us because this makes for an ideal combination of talents: LORENZ provides globally-proven software, and Pharma to Market is ideally situated with the local expertise to service our customers effectively.”

“As the market leader in eCTD solutions, LORENZ has a range of options to meet the needs of small companies operating in the region to multi-national organizations with an Australian and New Zealand presence. The LORENZ commitment and focus on e-Regulatory Affairs, combined with our local presence and expertise in the Australian and New Zealand markets provides an unparalleled range and depth of eSubmission products and services,” says Pharma To Market Co-Director, Johanna Hann.

As a first step in the strategic alliance, the two companies will exhibit together at this year’s ARCS Annual Scientific Congress in Sydney in June.

About Pharma To Market
Pharma To Market Pty. Ltd. is a regulatory affairs consulting company providing global regulatory support services for the pharmaceutical industry. Pharma To Market is proud to be the first company in Australia to offer services specialising in eCTD implementation and eCTD submission outsourcing. Pharma To Market is a privately held company in Brisbane, Australia, with over 50 years of experience in the pharmaceutical industry. For more information, visit the company Web site at www.pharmatomarket.com.

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 280 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.

Minimize the risk of FDA CDRH eCopy rejection: use LORENZ eValidator

Wed, 08 May 2013 00:05:00 +0000

Frankfurt, 8 May 2013 // The Center for Devices and Radiological Health (CDRH) is the FDA organization responsible for ensuring the safety of all medical devices and radiation-emitting products that are marketed in the U.S. Since January 1, 2013 the CDRH has been requiring an eCopy – an electronic duplicate of the paper drug or device submission – in parallel to the paper submission, which still remains mandatory.

Currently, about half of all CDRH eCopy submissions are being rejected, usually because they fail to comply with the new formatting standards. This causes major headaches: a rejection automatically places the entire submission on hold, and the producer is given 180 days to update and correct the eCopy issues that have been identified by the CDRH. The review process does not actually begin until a fully valid eCopy is received, and if a corrected version is not submitted within 180 days, the submission is considered withdrawn.

Red flag issues range from things as mundane as the file size, to more detailed errors in folder structure or naming. And the entire submission requires expert formatting of PDF documents, a specialty skill lacking at many Medical Device companies.

LORENZ has a simple way to help device producers minimize the risk of landing in the reject pile: eValidator. This is the world's most complete multi-region e-regulatory validation software, and the current version includes the CDRH eCopy format. The eValidator Basic version is available free of charge on the LORENZ website.

eValidator Basic also provides validation of US eCTD, EU eCTD, ZA eCTD (South Africa), CA eCTD, Swissmedic eCTD, EU NeeS, EU VNeeS, and STFs. This version includes a detailed analysis report, comprehensive profile content reports describing rules and validation criteria and a full-text search for rules.

The eValidator Professional provides extended validation profiles based on LORENZ’s extensive experience worldwide, including validation of JP eCTD, file and folder verification, in-depth PDF analysis, verification of referenced files and a host of other features. Explore the different versions of eValidator on the LORENZ website.

"This is an ideal solution for medical device manufacturers.” said Wolfgang Witzel, President of LORENZ Life Sciences Group, “Even the free version of eValidator can help keep submissions out of the reject pile.”

Tokyo docuBridge user conference brings Japan’s eCTD professionals together

Tue, 30 Apr 2013 00:04:00 +0000

Tokyo, 30 April 2013 // “Over the future” was the title of the third Japanese docuBridge user conference hosted by Digital Media System Co., Ltd.; LORENZ's exclusive distributor in Japan. The event attracted more than forty participants from the pharmaceutical industry and regulatory services.

Following dual introductions by Naoko Hayashi, Marketing Manager at Digital Media System Co., Ltd. and Raoul Lorenz, CEO of LORENZ Life Sciences Group, workshop presentations covered a range of subjects including:
• collaborative ASP-based submission compilation
• transitioning from an outsourced approach to an in-house system
• advanced structured document authoring
• automated submission post-publishing processes
• RPS (eCTD v4.0) perspectives

In the afternoon, three parallel tutorials were held focusing on specialized topics: submission management, document management and document authoring. Participants had the opportunity to discuss technical questions in detail and to make formal development requests.

"We are very proud" said Hiroji Emoto, President & CEO of Digital Media System Co., Ltd., "that, in the last few years, we were able to establish a fruitful communication between industry, consulting and also agency in Japan".

Wolfgang Witzel, President of LORENZ Life Sciences Group was also pleased with the workshop: "In addition to Digital Media System’s flawless organization" he said, "it was very gratifying to see such a large number of customers at this event, representing the majority of eCTD submissions processed in Japan".

About Digital Media System
Digital Media System Co., Ltd (DMS) is the exclusive distributor of LORENZ docuBridge in Japan. For further information please contact Telephone +81-3-5550-5595 or Web: http:/www.dms-jp.com/en/aboutus.html.

Factorytalk to market and service LORENZ products in Southeast Asia

Wed, 13 Mar 2013 00:03:00 +0000

Bangkok and Frankfurt am Main, 13 March 2013// Factorytalk, a Thailand and Singapore-based service provider for pharmaceutical companies and LORENZ Life Sciences, the world’s largest supplier of eCTDs, today jointly announced that Factorytalk will market, service and support LORENZ products throughout Southeast Asia.

“Factorytalk’s intimate knowledge of the life sciences market in Southeast Asia and the Pacific opens up new perspectives for us in these growing regions,” notes Wolfgang Witzel, President, LORENZ Life Sciences Group, “and as we see many Asian countries move towards CTD/eCTD/ACTD formats, the Factorytalk partnership makes us an interesting proposition for both industry players and regulatory authorities in the Asia-Pacific marketplace.

"LORENZ enables both authorities and applicants in the highly-regulated life sciences market to manage paperless submissions for drug applications. We believe that the resulting savings, in both efficiency and compliance costs that come from handling the procedure electronically is of great benefit to our industry. We’re proud to be teaming up with a leader in submissions management to bring this capability to ASEAN” commented David Margetts, Managing Director at Factorytalk. “Together with LORENZ, we are committed to delivering first-class technology and to ensuring that our customers have access to best practices in adherence to international standards and regulatory development”.

About Factorytalk
Factorytalk Co.,Ltd., founded in Bangkok, Thailand since 2004 has expanded rapidly across the SE Asia region with locations established in Singapore, Jakarta, Kuala Lumpur and Europe. Factorytalk provides services and solutions to pharmaceutical manufacturers and life science companies in Asia to increase performance and deliver compliance efficiencies. Factorytalk’s consultants are specialists in the optimization of quality management systems to met the most stringent of international regulations For more information about Factorytalk, visit www.factory-talk.com.
Contact: Ms Oracha Arthithanukati, Sales & Marketing Manager, Tel: +66-2-630-4525 ext 55, sar@factory-talk.com

Hands-on eCTD workshops underline the versatility of docuBridge

Thu, 28 Feb 2013 00:02:00 +0000

Frankfurt am Main, 28 February 2013 // Two hands-on workshops recently gave Indian and South African regulatory affairs professionals the chance to compile eCTD submissions using LORENZ docuBridge. Participants also used the software to re-purpose and replicate content for multiple authorities, underlining the overall convenience of the docuBridge solution.

In Mumbai, two separate one-day workshops were held in cooperation with DIA India on 4-5 February. Here, participants used docuBridge to compile, publish and validate two sequences of a US format eCTD. They then went on to re-purpose their compilation as an EU eCTD, and also replicated their US lifecycle changes to the EU eCTD with a click of a button. Beyond this, the 40 professionals attending the workshops also had the option to repurpose their submissions for South African, Saudi Arabian, Canadian, Swiss or Australian authorities.

"The Mumbai eCTD workshops focused primarily on understanding the eCTD submission structure, the re-usability of compiled content and what one has to pay attention to prior to submitting a submission to the authority for approval," said Kent Briggs, Director of Professional Services at LORENZ. "The majority of participants had only worked on CTD paper-based submissions, so getting to work with the eCTD in a hands-on environment was a huge step forward for many of them.”

A week earlier on 30-31 January near Johannesburg, South Africa, LORENZ co-hosted a two day hands-on workshop together with MRA Regulatory Consulting on transitioning to the eCTD process. The 50 participants here compiled and prepared the print output for two sequences of a South African CTD, including the automatic creation of table of contents and tab and slip sheets using LORENZ's docuBridge.

"The South African market is really starting to move fast in the direction of eCTD" said Robyn Daniel, Director and Partner at MRA. "Over the past 12-18 months, we have submitted close to 250 applications in CTD format for our clients. We wanted to share those experiences with others and show just how easy it can be to submit well-structured paper CTDs. A well-organised application is easier to review and can even lead to faster decisions."

"South Africa is just one of many African countries moving towards CTD/eCTD" said Michael Schultz, Director of Sales at LORENZ. "We are excited by what we have seen here and are happy to underline just how easy eCTDs can be. The re-usability of content already compiled will help many companies here who are also responsible for preparing submissions in other African countries."

With the recent release of South Africa’s eCTD specifications by the MCC, LORENZ has been asked to offer another workshop there to focus specifically on the South African eCTD, its compilation and validation.

South African eCTD Workshop - trained by Kent Briggs

In both workshops, “users were surprised how easy it was to compile a submission, re-purpose content and replicate lifecycle changes. They very much understood how much work LORENZ docuBridge can save them," said Briggs.

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 280 installations in over 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.

Warm and dry to a loved one’s resting place

Thu, 20 Dec 2012 00:12:00 +0000

Electric-powered minibus circulates through Frankfurt’s Main Cemetery
Donation from the LORENZ Foundation

Frankfurt am Main, December 20, 2012 // The Main Cemetery of Frankfurt sprawls over more than 70 hectares. The philosopher Theodor W. Adorno, the author Ricarda Huch, the paediatrician Heinrich Hoffmann who created the German children’s tale Struwwelpeter, and countless other personalities have their final resting place here. “At the Main Cemetery, you encounter figures from both German and local history”, says Frankfurt businessman Heinz-Jürgen Lorenz. But above all, the cemetery is a place of pilgrimage and remembrance for the many city residents who come to visit the gravesites of their departed relatives.

A year ago, the LORENZ Foundation donated a cemetery taxi to enable those who are not so steady on their feet either due to age or infirmity, to visit the graves of their loved ones. Now the Foundation is strengthening its engagement with a successor model that offers even more comfort and which like its predecessor, can be used free-of-charge by anyone. On Thursday, 13 December 2012, Stephan Heldmann, the head of the municipal parks department, accepted the keys to the vehicle from the hands of Heinz-Jürgen Lorenz and his daughter Nadine.

“The LORENZ Foundation is a comparably small charitable institution, so it is important to help people directly with simple things that make day-to-day life easier and which provide an element of happiness”, said the founder of the LORENZ Group, which is headquartered in Frankfurt-Rödelheim. From his many discussions with elderly and people with mobility problems, he knows just how important the visit to a relative’s graveside can be for them. Department manager Heldmann agrees: this winter-suited cemetery taxi is an enrichment that the city simply could not have afforded on its own.

Heldmann also praised the technical characteristics of the vehicle: it is fully enclosed and therefore much easier to heat than the previous model. The new LORENZ-Mobile has sliding doors, steps for access, and offers room for three passengers plus accessory gear such as a wheelchair. At the same time, the bus is narrow enough to be able to approach the graves directly, and with its quiet electric propulsion, no one else is disturbed.

One person who’s definitely in a position to judge the new taxi’s suitability for everyday use is Willi Erb. He’s the driver of the open taxi that circulates around the cemetery in the summertime, and will also be driving the LORENZ-Mobile during the colder months. He had a chance to drive the vehicle in advance, and in his opinion, the test drives were very convincing. Even with temperatures below freezing as they were on the day of the official handover, no elderly person need freeze on their way to visit a loved one’s grave.

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 250 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.

Groundbreaking eCTD Workstation Solution from LORENZ Life Sciences Group

Wed, 19 Dec 2012 00:12:00 +0000

Frankfurt am Main, December 19, 2012 // LORENZ Life Sciences Group launched today their groundbreaking new offering in the US market – docuBridge ONE, the eCTD Workstation Solution.

docuBridge ONE is a token-based, single user eSubmission solution downloadable to a user’s workstation from www.lorenz.cc in less than five minutes. “The eCTD expertise we have amassed through having LORENZ docuBridge used in hundreds of companies spanning the globe is now packaged as an affordable option for the ad-hoc eCTD publisher,” said Yaprak Eisinger, MD North America, who has already been informed by a number of interested companies that they intend to begin making online purchases to pilot docuBridge ONE before the end of 2012.

Industry experts are impressed and excited by the opportunities dB ONE will bring to the world of electronic submissions. “With docuBridge ONE, LORENZ has set a Life Sciences industry benchmark for eCTD software affordability, ease of installation, and access to high-quality support. docuBridge ONE is groundbreaking for those life sciences companies needing a cost effective solution for their eCTD publishing challenges. I intend to recommend dB ONE for all my clients who want to control their eCTD submissions,” said Antoinette Azevedo, President & CEO of esubmissionssolutions.com.

Announced in October at both the DIA “EDM and ERS/eCTD” and the 2012 RAPS “ The Regulatory Convergence” conferences, docuBridge ONE was hailed as the long-awaited solution by enthusiastic regulatory professionals conceptualizing the solution’s many potential markets: consultants and CROs who like its “pay-as-you go” with a token approach and small companies who can’t afford to make a large upfront investment when they have not yet built the infrastructure for eSubmission.

David Zuchero, President, Chesapeake Regulatory Group, Inc., an ideal customer for docuBridge ONE, said “CRG is a regulatory affairs consulting firm that’s been in business for over 20 years. For a number of years I’ve been looking for a cost-effective way to provide electronic submission services to our clients. After demo-ing docuBridge ONE I think we’ve found the solution. docuBridge ONE looks like a great eSubmission solution for smaller service providers like us, without a significant upfront investment. We’re looking forward to the launch of dB One and the opportunity to provide this service to all of our clients.”

“LORENZ made a substantial investment to bring docuBridge ONE to market with such ease of use and secure payment capabilities,” said Wolfgang Witzel, President of LORENZ Life Sciences Group, adding that “Customers need to feel safe when they use their credit cards to purchase docuBridge ONE tokens or support hours. We created a secure infrastructure, allocated dedicated docuBridge ONE support staff and designed e-learning modules – all to make LORENZ docuBridge simple and affordable to the average ‘Joe the Publisher.”

For more information on dBONE, visit:
http://www.lorenz.cc/eSolutions/docuBridge-one/ or call 1 866 LORENZ - 1 866 956 7369.

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 250 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click www.lorenz.cc

LORENZ Frankfurter Podium: Drohung mit dem Ende als Chance für den Euro [GERMAN]

Thu, 08 Nov 2012 00:11:00 +0000

Frankfurter Podium der LORENZ Systemhaus-Gruppe am 5. November 2012 // Dabei sein ist alles, lautet das olympische Motto. Das schließt freilich nicht aus, dass man mit herausragenden Leistungen auch etwas gewinnen kann. So wie Vico Merklein. Der Handbiker, der bei den Paralympics in London Silber im Straßenrennen holte, war am Montagabend Ehrengast unter den mehr als 200 Gästen des Frankfurter Podiums der LORENZ Systemhaus-Gruppe.

Dabei sein ist alles – so könnte auch das Motto der Euro-Zone heißen. Ob es dabei aber etwas zu gewinnen gibt, erscheint immer zweifelhafter. Möglicherweise könnte sogar Deutschland, das europäische Vorbild an Solidität und Wirtschaftskraft, am Ende als Verlierer dastehen. Und so ist ein Abend, der sich mit dem Euro beschäftigt, am Ende auch ein Abend, bei dem über die Zukunft des größten Mitgliedslandes verhandelt wird.

„Ist Deutschland noch zu retten?“ und „Zurück zum No-Bail-out-Prinzip oder Gemeinschaft um jeden Preis?“ lauteten die Fragen, mit denen sich die Expertenrunde am Unternehmenssitz in Frankfurt-Rödelheim auseinandersetzte. Unter der Leitung von Hans D. Barbier diskutierten der Publizist und ehemalige Bundesbank-Vorstand Thilo Sarrazin, der Makroökonom und Professor der Berliner Humboldt-Universität, Michael C. Burda und Roland Tichy, Chefredakteur des Magazin Wirtschaftswoche.

„Ich glaube, die Welt wartet auf eine Entscheidung aus Deutschland“, sagte Gastgeber Raoul Lorenz einleitend. Wenn Moderator Barbier diese zu treffen hätte, würde er vermutlich nicht zögern. Die Einführung des Euro, daran ließ er in einer gewohnt meinungsstarken Moderation keinen Zweifel, sei ein katastrophaler Irrtum gewesen. Selbständige Staaten könnten keine gemeinsame Währung haben, zumal ohne wirksame Sanktionen bei Regelverletzungen.

Ja, die Politik habe große Fehler gemacht, räumte Burda ein. „Aber die Zahnpasta ist aus der Tube raus, wir kriegen sie nicht mehr hinein.“ Die Entscheidungen der Vergangenheit könnten nicht ungeschehen gemacht werden, auch nicht, indem man Staaten wie Griechenland aus der Währungsunion werfe oder diese selbst verlasse. „Wir müssen nach vorne schauen – und müssen auch helfen.“

Doch ist es klug, immer weiter zu gehen, wenn die Richtung womöglich falsch ist? Euro-Skeptiker Sarrazin griff zum Bild der Bergsteigergruppe, die falsch abgebogen ist und sich nach fünf Stunden Fußmarsch in einem Geröllfeld wiederfindet. Dann zu sagen, man habe es ja gleich gewusst, sei müßig. Andererseits, so Sarrazin, sollte man die Analyse, die ins Geröllfeld geführt hat, wenigstens kritisch überprüfen.

Dabei werde sich nach Meinung des ehemaligen Bundesbankers manche Behauptung als falsch erweisen. Zum Beispiel, dass der Euro dem deutschen Außenhandel genutzt habe. „Dafür gibt es null Evidenz.“ Staaten wie die Schweiz oder Schweden zeigten, dass der Export auch ohne Einheitswährung florieren könne. Geradezu heilsam seien Währungsunterschiede für Staaten mit schwächerer Wirtschaft. Das habe sich nach dem Ende des Bretton-Woods-Systems gezeigt, als beispielsweise eine Abwertung des Francs boomende französische Exporte bewirkt habe.

Kaum stichhaltiger als die wirtschaftlichen seien die politischen Argumente für die Währungsunion, sagte Tichy. Der Euro habe sein Ziel nicht erreicht, Europa zu vertiefen, er reiße es auseinander. Sein Fazit: „Wer Europa liebt, der muss nicht den Euro lieben.“ Wenn es aber doch eine Chance für die Gemeinschaftswährung gebe, dann liege sie in einer glaubwürdigen Drohung mit ihrem Ende, sagte Tichy in geradezu Marxscher Dialektik.

Burda pflichtete bei: Eine Drohkulisse sei essentiell, um überschuldete Länder zur Einhaltung von Sparauflagen zu bringen. Allerdings müsse sich auch Deutschland klar darüber sein, was passiere, wenn aus der Drohung eines Tages Wahrheit werde. Steige Deutschland aus dem Euro aus, dann führe das zu einer Bankenkrise. Alle Verbindlichkeiten in südlichen Ländern wären verloren.

Für Griechenland wäre das Ende der Währungsunion ein Neuanfang, sagte Sarrazin. Nach einem ersten Schock könne die Wirtschaft dank abgewerteter Währung wieder wachsen. Nach Meinung Tichys könnte das Aus für den Euro sogar einvernehmlich beschlossen werden. „Ich wehre mich dagegen, dass man den Euro zum Popanz macht, zu einer Fessel. Er nimmt uns die Luft und den anderen auch.“ Gegen einvernehmliche Lösungen hätte Burda nichts einzuwenden, ganz im Gegenteil: „Wie wäre es mit einem Schuldenschnitt?“ Schließlich hätten die reichen Länder bei einer griechischen Insolvenz auch massive Kosten zu tragen – dieses Geld könnten sie ebenso für eine Sanierung und Modernisierung des Landes aufwenden.

Wie auch immer die Entscheidungen ausfielen – sie müssten getroffen werden, sagte Raoul Lorenz. Wenn die Politik das Vertrauen der Menschen nicht verlieren wolle, müsse sie aufhören, zu taktieren. Es bedürfe einer Strategie für Europa, sagte er und schloss mit einem Appell an Diskussionsteilnehmer und Gäste. „Bringen Sie sich am Verhandlungstisch mit ein – es geht um die Zukunft.“ Ein Bericht von Matthias Trautsch - Redakteur der FAZ

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 250 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.

NEWS In Brief: BfArM Announces widening of eSubmission Only Procedures

Thu, 25 Oct 2012 00:10:00 +0000

Frankfurt am Main, October 25, 2012 // The BfArM (German Federal Institute for Pharmaceuticals and Medicinal Products) announces that it is widening the scope of so-called "eOnly" submissions. Change notices and extension applications will now also be accepted in a primarily electronic format for those approvals that were submitted prior to 31 March 2010. Conditions do apply, and the general requirement to submit certain additional documents in paper form remains. See the BfArM website for further details in German: http://www.bfarm.de/DE/Home/news/eSubmission.html.

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 250 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.

userBridge.12 draws rave reviews from participants

Mon, 22 Oct 2012 00:10:00 +0000

Frankfurt am Main, 22 October 2012// More than 160 participants from 23 countries assembled at Dublin’s Clontarf Castle in September for userBridge.12, the global e-regulatory conference organised by LORENZ Life Sciences Group, the world’s largest supplier of eCTDs. Attendees rated the Dublin event highly for its mix of presentations from industry and from agencies, its lively debates and informative table tutorials, and generous time for networking.

e-Regulatory Forum: how many portals can a pharmaceutical company manage?
As a major worldwide forum for Regulatory Affairs professionals, the conference did not shy away from grappling with difficult questions. In the e-Regulatory Forum debate moderated by Dr. Christine Mayer-Nicolai of Merck KGaA, panellists Suzanne McDonald of the Irish Medicine Board, Andrew Marr of the Marr Consultancy Ltd. and Dr. Barbara Gansewendt from Bayer Pharma AG considered the recent growth in national and European regulatory requirements, including xEVMPD. A lively discussion focussed on the delicate balance regulation should strive for in terms of reconciling the need for documentation requirements and patient safety with the timely and cost-efficient provision of medications.

from left: Suzanne McDonald, IMB - Dr. Christine Mayer-Nicolai, Merck KGaA
Dr. Andrew Marr, Marr Consultancy Ltd. - Dr. Barbara Gansewendt, Bayer Pharma AG

Speeches and Table Tutorials provide interest and learning
A total of 18 speakers from industry, consulting and regulatory agencies presented at this year’s userBridge conference; just three of the speakers from LORENZ. The first guest speaker was Dr. Dietmar Böcker of Bayer Pharma AG who outlined how docuBridge assists his international teams in cooperating on compilations globally with one single platform. Other highlights were provided by Karl-Heinz Loebel from PharmaLex GmbH who drew a clear outline of the growing requirements posed by xEVMPD and how they will need to be integrated into a software solution, and by Roman Schächle of the Austrian agency AGES, who outlined how the symbiotic relationship between agency and software provider means that resolving issues for one customer can translate into software improvements for many others.

On the afternoon of the second day of the conference, a total of 21 Table Tutorial sessions covering 16 topics gave the opportunity for hands-on learning about specific topics in very small groups, in highly personal and interactive format. The Table Tutorial offer ranged from how to set up and use the FDA Gateway, upgrading from dB 3.6 to 5.0, and eValidator issues, to drugTrack and EVMPD developments.

Agency Day follows userBridge
Immediately following userBridge, regulatory agency customers from various countries from stayed on for the Inter-Agency Discussion Group. This event for the agency users of LORENZ docuBridge software allowed in-depth discussion on topics such as e-validation criteria in Europe and RPS. It also provided a forum to discuss how docuBridge and eValidator could be used more effectively in an agency setting. The insights that emerged will be verified in practical testing and further developed in collaboration with the participants.

Rave reviews
Many userBridge.12 attendees such as Kevin Horan of the Irish Medicines Board and the consultant Andrew Marr praised the conference as one of the best in its field. “We’re very pleased with the resonance from userBridge participants”, notes Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group “and the level of engagement from our Irish hosts was inspiring.” Amy Williamson of NDA Regulatory Science Ltd. summed up the sentiment of attendees when she thanked LORENZ “for a brilliant conference with great speakers, informative table tutorials, accommodating staff and wonderful evening entertainment . . . See you next year at Strasbourg if not before!”

Save the date for Strasbourg: 17-19 September 2013
The French city of Strasbourg will be the setting for userBridge.13, which will be held from 17-19 September 2013. This will be directly followed by the Agency Day on 19-20 September 2013.

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 250 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.