60 LORENZ Life Sciences News Feed List of all press releases issued by LORENZ. http://www.lorenz.cc <![CDATA[State Institute for Drug Control (SÚKL) of Czech Republic will review electronic submissions using LORENZ docuBridge]]>

Praha, 10 November 2016 // The LORENZ docuBridge software solution has been selected by the SÚKL (State Institute for Drug Control) located in Praha, Czech Republic for that agency’s work in receiving, reviewing and processing electronic applications for market authorizations. The SÚKL will combine docuBridge with the LORENZ Automator service for the automated download of electronic submissions from the EMA CR.

“We’re very proud that the SÚKL have placed their trust in us for handling eCTDs and NeeS” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Our global experience is helping more and more Health Agencies like SÚKL ensure that their review of electronically created submissions runs as efficiently and smoothly as possible. There are also significant advantages in time-saving and in the storage and handling of regulatory files. The fact that SÚKL is coupling docuBridge with the use of LORENZ Automator for its downloads from the EMA is also significant. It marks an important milestone for both LORENZ and the SÚKL.”

LORENZ docuBridge addresses all the fundamental business challenges of an eReview process, and complies with all global eCTD standards and NeeS. The software is already used by many other authorities globally, including Health Canada, the German Federal Institute for Drugs and Medical Services (BfArM), the Australian Therapeutic Goods Administration (TGA), and the Thai FDA.

 

About SÚKL
The Czech State Institute for Drug Control is an administration body established by the Act no. 79/1997 Coll. It falls under direct control of the Ministry of Health. The scope of operation of the Institute is stipulated by legal regulations. In order to safeguard its tasks, the Institute establishes regional workplaces located outside the headquarters of the Institute. The Institute's mission is, in the interest of public health protection, to ensure that all human pharmaceuticals available on the Czech market meet appropriate standards of quality, safety and efficacy to take share to ensure that only safe and functional medical devices are used in the Czech Republic, in addition, accompanied by reliable and appropriate information. Moreover, its role is to contribute to rational use and where appropriate, to responsible and ethical clinical trials of both medicinal products and medical devices.
Regulatory procedures shall not result in unnecessary obstacles to the availability of medicinal products and medical devices nor to introduction of new therapeutic procedures.

 

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 has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=220 Thu, 10 Nov 2016 00:11:00 +0000
<![CDATA[Interoperable systems and standards are the hot topics at userBridge.16 conference]]>

Frankfurt/Main, 19 October 2016 // Hamburg, a seafaring city with a long tradition of international trade was the setting for this year’s userBridge conference, the global e-regulatory affairs gathering organized by the LORENZ Life Sciences Group, the world’s premier supplier of eCTD solutions. Held from 20-22 September, the sold-out userBridge.16 event attracted 172 participants from 21 countries. Interoperability of systems and the importance of converging standards were the hot topics of discussion among leading personalities from both industry and agencies.

In keeping with tradition, userBridge.16 also included a wide selection of small-scale table tutorials. The overall program was also designed to give participants plenty of time to network and exchange their individual experiences in a familiar yet professional atmosphere.

Interoperability and convergence of standards
In his opening keynote speech, Raoul-A. Lorenz, CEO of the LORENZ Life Sciences Group again highlighted the importance of interoperability, i.e. the ability of different IT systems and software applications to communicate and exchange data. He also pleaded for a convergence of standards to increase efficiency for the industry.

In that spirit, the multi-day program of presentations kicked off with an update on IDMP implementation given by Andrew Marr of Marr Consultancy Ltd. Likewise, a major related topic on the first day was the new US Module 1 v.3.3 and the onward path to eCTD 4.0. That transition was the topic of a presentation by LORENZ’s Jared Lantzy, who also delivered a related table tutorial. Dr. Andreas Franken from the BAH, Germany’s association of pharmaceutical manufacturers spoke about challenging the ICH eCTD 4.0 Implementation Guide from an industry perspective, while Dr. med. Klaus Menges of BfArM, Germany’s Federal Institute for Drugs and Medical Devices, gave an agency view of eCTD 4.0 implementation.

In addition to standards, making processes more efficient in themselves was also a topic at userBridge.16. Margaret Hurley of Hurley Consulting Associates Ltd. outlined her thoughts on how to expedite the preparation of drug development documentation for compilations, while PharmaLex GmbH’s Timm Pauli spoke on leveraging the possibilities for efficient dossier and submission processes that are already offered today, and others that will be available tomorrow.

Global advance of eCTD
The userBridge conference is a global event, and the roll-out of eCTD in different parts of the world also figured prominently in several presentations. Dr. Athiporn Doomkaew & Sira Janpeng of Thailand’s FDA outlined the agency’s challenges in moving from paper to eCTD in just three years. Don Lebitsa of Adcock Ingram Limited shared lessons learned from South Africa’s experience in eCTD implementation.

Table Tutorials
On the morning of day two, 28 table tutorial sessions gave conference participants the chance to learn about specific topics in smaller-scale face-to-face discussions and demonstrations. Topics covered ranged from specific product-related matters such as LORENZ docuBridge configuration and using LORENZ Automator to dispatch a submission in just one click, on to wider topics such as how to get documents submission-ready, and the new EU Module 1 version 3.

“The quality of presentations and the tutorials at userBridge.16 was outstanding because they really highlighted both the challenges and the solutions offered by interoperability and new standards,” notes Raoul-A. Lorenz, CEO of the LORENZ Life Sciences Group, “and once again we are really pleased to receive so much positive feedback from our participants, who value userBridge for the opportunity to keep up-to-date with the latest developments in regulatory affairs.”

Agency Day
After the conference, agency regulators once again took the opportunity for an Inter-Agency eSubmission Discussion Group Meeting organized by the German BfArM. 19 representatives of 10 national agencies discussed about interacting projects with EMA and their impact on national health agencies as well as different topics around the usage of eCTD.

  

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 has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With close to 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=219 Wed, 19 Oct 2016 00:10:00 +0000
<![CDATA[FDA awards LORENZ eCTD Contract]]>

Philadelphia, 07 October 2016 // LORENZ Life Sciences Group is pleased to announce that the U.S. Food and Drug Administration (FDA) awarded LORENZ with an “Electronic Common Technical Document (eCTD) Validation and Review Software” contract on September 30, 2016 through a competitive procurement process.

LORENZ will implement its docuBridge, eValidator and Automator solutions in FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) electronic submission programs. CDER and CBER will use the LORENZ product suite to validate and review incoming and legacy eCTD submissions.

“We remain dedicated to Engineering the World’s Most Desirable e-Regulatory Solutions,” said Wolfgang Witzel, President LORENZ Life Sciences Group, adding that “it is an honor to be chosen by the FDA and we view this as testament to the quality of LORENZ employees, products and solutions.”

“The partnership between the two organizations will kick off immediately in October 2016 and we will work together to ensure a smooth transition,” said Yaprak Eisinger, Managing Director, North America.

Questions regarding the FDA-LORENZ partnership or other partnerships LORENZ has with leading health agencies around the world can be directed to Jared Lantzy, Manager of Global Regulatory Agencies and Processes, jlantzy [at] lorenz.cc.

 

About LORENZ Life Sciences Group
LORENZ Life Sciences Group has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as our ability to Automate processes allow LORENZ customers to achieve operational efficiencies their competitors are not used to. To learn how thousands trust LORENZ, go to www.lorenz.cc or www.lorenz.cc/Corporate/index.cfm.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=218 Fri, 07 Oct 2016 00:10:00 +0000
<![CDATA[Two South African companies qualify for the LORENZ docuBridge 1K Club]]>

Pretoria and Frankfurt/Main, 30 September 2016 // LORENZ Life Sciences Group is happy to introduce the latest members to the 1K Club and the first to qualify in Africa. DI Regulatory Consultants and MRA Regulatory Consultants have both recently announced they have compiled over 1,000 submissions using the LORENZ docuBridge system.

"Africa is very quickly adopting the CTD as the standard structure,” said Robyn Daniel, Director at MRA Regulatory Consultants. “Content re-use has enabled us to work more effectively across the region and as more regions like the EAC and ZAZIBONA harmonise, there will be even more opportunities to grow our business."

"LORENZ has been dedicated to promoting CTD and eCTD in Africa since the South African MCC first took steps towards the international standard in 2010,” said Michael Schultz, Director Sales – Middle East, Asia Pacific & Africa at LORENZ Life Sciences Group. “Our first customers there are now reaching the first milestone of 1,000 submissions compiled, others are quickly approaching that mark."

"As guidance and regulations change, technology has enabled us to focus on the quality and content of the applications for our customers,” said Rudi Oliver, Director at DI Regulatory Consultants. "Our customers benefit from our ability to work more efficiently which also enables us to compile applications faster with consistent high quality output."

Logos MRA and DI Regulatory

LORENZ began awarding its customers the 1K Club designation in 2008 and have since implemented additional clubs for 5K, 10K, 15K and 25K. Up until now, those clubs have been filled with customers from the core ICH regions but now companies from other regions begin meeting the requirements. Six years after the initial launch of the CTD in South Africa, customers there are now joining the ranks.

"There has been a misperception in the market that submission management systems are only necessary if and when you decide to go eCTD," said Kent Briggs, Director at VECTOR Life Sciences. "In fact, LORENZ docuBridge provides vast time saving opportunities for paper based applications. It helps you standardise your processes, streamlining compilation work into an efficient systematic production." DI and MRA learned this quickly and have been producing submissions regularly ever since.

 

About DI Regulatory Consultants
DI Regulatory Consultants has been serving the pharmaceutical industry for the past 25 years and offers a complete range of regulatory services, to both local and international clients. Our company philosophy is based on partnership with our clients to achieve optimum regulatory outcomes with guidance from molecule inception and pharmaceutical manufacturing to regulatory approval and marketing of products. We also provide auditing services assisting customers to achieve current Good Manufacturing Practises (GMP) of APIs and finished products, Good Laboratory Practises (GLP) and Good Wholesale/Warehouse Practises (GWP). We aim to share our vast knowledge economy in veterinary, orthodox and complementary medicines as well as medical devices with our partners in industry.

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 close to 600 paid installations in over 30 countries, LORENZ has a strong worldwide customer base.

About MRA Regulatory Consultants
MRA Regulatory Consultants was established in 2003 to provide expert regulatory advisory services and regulatory support services to the pharmaceutical industry. We enjoy a clear understanding of the regulatory environment in South Africa, its history, trends, current requirements and policies. We are associate members of many of the industry associations and in our professional capacities affiliated to the professional associations. We aim to empower our customers with the knowledge and understanding of the regulatory environment and processes to enable them to make informed decisions regarding their products.

About VECTOR Life Sciences
VECTOR Life Sciences (www.vectorls.co.za) is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. We support both industry and regulators in their transition from paper based methods to electronic processes. Our extensive Experience includes the installation and validation of regulatory systems, regulatory and submission (CTD/eCTD) training of both industry and national authorities, regulatory process consulting and application compilation. Our entire team is based in South Africa providing you with quick and local support. VECTOR Life Sciences is the distributor and service provider for LORENZ Life Sciences in Africa.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=217 Fri, 30 Sep 2016 00:09:00 +0000
<![CDATA[Digital Media System and LORENZ elaborated the specifics of Japanese eCTD]]>

Tokyo and Frankfurt/Main, 29 August 2016 // Following the 2nd International Symposium of the Japan eCTD Society on May 24, 2016 in Tokyo, the partner companies Digital Media System and LORENZ initiated a taskforce to work on a knowledge base covering the specific items relating to eCTDs submitted to PMDA, the regulatory agency for pharmaceuticals and medical devices in Japan.

The Japanese eCTD's technical aspects are defined by the written specification and the official regional schema. These are addressed by established software solutions like LORENZ docuBridge. However, the taskforce went even further and investigated aspects of content section, validation and application submittal procedure that are specific to Japanese regulations.

This knowledge base is now an essential resource for global pharmaceutical companies on Japanese eCTDs. Even though a global regulatory affairs department can process/publish eCTD submissions for many regions with one centralized team, this approach is usually not successful for Japan.

Hiroji Emoto, President and CEO of Digital Media System Co., Ltd. noted that "with docuBridge we can utilize our specialized knowledge to provide eCTD service and consultancy to our customers in Japan very efficiently."

"Our joint knowledge that we have assembled over one decade enables us to combine our software with the services appropriate to specific regional requirements - a reason why we have an exclusive partnership with Digital Media System for Japan. This is also the reason why all our agreements with other global partners always exclude Japan," said Wolfgang Witzel, President of LORENZ Life Sciences Group.

People interested to learn more about the distinct items related to eCTD submitted to PMDA may contact Digital Media System and LORENZ directly.

 

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 close to 600 paid installations in over 30 countries, LORENZ has a strong worldwide customer base.

About Digital Media System Co., Ltd.
Digital Media System Co., Ltd. (DMS) is the exclusive distributor of LORENZ docuBridge in Japan. Beside the submission management system, DMS also established expertize among partners to provide a Premium eCTD Compilation Service for eCTD applications to the Japanese authority. For further information please contact Telephone +81-3-5550-5595 or Web: www.dms-jp.com.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=216 Mon, 29 Aug 2016 00:08:00 +0000
<![CDATA[LEARN, DISCUSS, and INTERACT at LORENZ userBridge.16 in Hamburg, Germany]]>

Frankfurt/Main, 13 May 2016 // The Atlantic Kempinski Hotel Hamburg will be the setting for userBridge.16, the annual regulatory affairs conference hosted by LORENZ Life Sciences Group. From 20-22 September 2016 experts from industry and government authorities will gather to network & discuss the latest trends and insights in regulatory affairs based on the userBridge motto LEARN-DISCUSS-INTERACT.

 

Conference highlights will include a range of informative presentations such as:

IDMP Update: What is coming in 2017?

Automating Regulatory Process: Becoming More Efficient

RPS & eCTD v4.0: The Path To Implementation

Planning, Compiling and Reusing eCTDs

IDMP Implementation Planning using drugTrack

Migration Project Management: Migrating 1000s of Submissions

Cloud to Cloud Interoperability: Cloud Applications in a Validated/Compliant Environment

Table Tutorials on the second day will give participants the chance to cover specific topics in interactive discussion groups

 

 

To get an impression of the conference, watch our userBridge video.
If you are interested in presenting a topic from the list above, please send a short abstract of your presentation topic to Michael Schultz.

We look forward to welcoming you to Hamburg!

 

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 close to 600 paid installations in almost 30 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=215 Fri, 13 May 2016 00:05:00 +0000
<![CDATA[LORENZlink 2016 - LORENZ Life Sciences Group hosts its first North American conference focusing on Regulatory Information Management]]>

Philadelphia, 13 April 2016 // LORENZ Life Sciences Group was proud last week to host LORENZlink, its first North American conference. The event held in Scottsdale, Arizona was launched to focus on LORENZ’s ever-growing North American customer base and interoperability partners, to supplement LORENZ’s annual global user conferences held since 2003. The sold out event attracted close to 90 participants from industry and regulatory health agency sectors.

A panel discussion moderated by Antoinette Azevedo brought experts from Biovia, CSC, Court Square Group, MasterControl and Veeva Systems to discuss Challenges of Content Management and Submission Planning in the Cloud.

While Irena Pastorekova from Health Canada gave an Update on Electronic Submissions in eCTD and non-eCTD formats, Karen Chiang from Intrinsik Health Sciences spoke about NDS Submissions to Health Canada. Jared Lantzy, former FDA expert now with LORENZ, spoke about RPS and eCTD 4.0: The Path to Implementation, while Daniel Cartin and Sandra Krogulski of Accenture Accelerated R&D Services presented How to Avoid Stumbling Blocks Transitioning to the new M1 Specifications.

Dr. S. Albert Edwards spurred the discussion on Driving Toward One Desired Vocabulary: RIM and IDMP. Aspects of Change Management and Career Development were presented by Jami Donohue and Lynn Hansen, encouraging further dialogue. Jennifer Kutlesa of Bayer Inc. Pharmaceutical Division presented a case study on Automating eCTD Processing using the LORENZ Automator, while Khaled Yahiaoui of Pharmascience demonstrated Improving Regulatory Publishing KPIs using docuBridge.

Numerous tutorial sessions held on the second day of the conference in smaller groups examined advanced topics in Microsoft Word, preparing for IDMP requirements using drugTrack, leveraging docuBridge to increase operational efficiencies and submitting to the FDA using new US Module 1 specifications.

The agenda included many other intriguing presentations echoing the overall theme of Converge, Connect, Collaborate, and drew praise from attendees. LORENZ Product Roadmaps were shown and product demonstrations were held during the coffee breaks. Sunny weather, flowering cacti and ample time for lunch and dinner conversations provided the perfect setting for an invaluable 3-day conference, the last day of which was an optional docuBridge training event.

“We are grateful to have had such a positive response to our first North American conference highlighting important industry topics in Regulatory Information Management with a distinguished faculty of LORENZ staff, customers and partners,” said Yaprak Eisinger, MD North America, adding that the date and location of the next LORENZlink event would be announced in the near future on LORENZ’s website, www.lorenz.cc.

 

 

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 close to 600 paid installations in almost 30 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=214 Wed, 13 Apr 2016 00:04:00 +0000
<![CDATA[The Countdown to LORENZlink Begins]]>

Philadelphia, 20 January 2016 // LORENZlink, LORENZ’s first North American conference in Regulatory Information Management will take place during April 4-6 in Scottsdale, Arizona. While the first 2 days of the conference will feature presentations and tutorials held by a distinguished faculty of LORENZ customers, partners and employees, the third day will focus on docuBridge training, outlining new and upcoming features in 5.8 and 5.9.

LORENZlink’s philosophy will be to Converge, Connect and Collaborate and as such, many LORENZ customers and partners will share their own practical experiences and best practices relating to current hot topics, trends, products and services in regulatory affairs.

 

April 4-5, 2016

Some examples of what will be covered are:
• eCTD Mass Production: Impact on Operational Efficiency and KPIs
• LORENZ docuBridge Interoperability Features: Improving Regulatory Publishing KPIs
• RPS and eCTD v4.0: Current Regulatory Landscape and Path to Implementation
• Regulatory Updates - FDA, Health Canada, TGA, Thai FDA and eCTD v4.0
• Innovation in Academia: LORENZ docuBridge as an eCTD Enabler
• Driving Toward One Desired Vocabulary: RIM and IDMP - Passengers or Drivers?
• Submission Business Process Interoperability Between Organizations: Above and Beyond Software
• New US Module 1 Specifications: Business Case Study on Successful Regulatory Submissions to the FDA
• docuBridge 5.8 and Beyond: Leveraging New Features to Increase Operational Efficiencies
• LORENZ drugTrack: Leveraging New Features to Manage Regulatory Data and Prepare for IDMP Requirements
• Migration Projects Practices: Steps for Efficiently Moving to a New Submission Management Tool
• Best Practices for Preparing Submissions to Multiple Regions: A Business Case Study on a Successful Global Business Process
• Microsoft Word Master Class: Insights and Tips for Better Content Creation and Management

 

April 6, 2016

The LORENZlink conference is followed directly by a docuBridge Training. Attendees will learn how to create a new application (using US version 3.3) and the basics of compiling modules 1 (Regional Information), 2, 3, 4 and 5 (STFs). Multiple user editing, hyperlinks and bookmarks, reference node and cross application referencing will all be covered. Participants will re-use data by merging and cloning applications as well as manage the lifecycle of their applications.

Please note that the number of seats available for this training session is limited, so attendees are requested to book early, and are also kindly asked to bring their own laptops.

 

 

“The LORENZlink conference and the docuBridge training day will give our North American customers the opportunity to experience the rich exchange of ideas that LORENZ events are so well-known for in our industry,” says Yaprak Eisinger, MD North America, “and we look forward to welcoming everyone to Scottsdale very soon.”

For more information and to register, please click here.

 

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=213 Wed, 20 Jan 2016 00:01:00 +0000
<![CDATA[Strategic Partnership between CSC and LORENZ]]>

Frankfurt/Main, 08 January 2016 // LORENZ Life Sciences Group and CSC, a global leader in next-generation IT services and solutions, have agreed to add LORENZ’ offerings to the CSC portfolio of software to help Life Science’s clients improve the end to end publishing experience. This new relationship will allow the two organizations to work together to provide the market-leading, most-comprehensive Digital Regulatory Information Management (RIM) solution suite for submissions management.

CSC’s clients will have the opportunity to choose between the current CSC products, as well as the LORENZ product suite (docuBridge, Automator and eValidator). Under the strategic partnership between LORENZ and CSC, LORENZ docuBridge will become a fully-supported, complementary product set to the TRS Submission Management suite of CSC as CSC becomes the strategic partner for Systems Integration (SI) and services of LORENZ.

Over the coming months CSC and LORENZ will be working closely as they formalize the agreements to establish a clear and straightforward path to allow current and future TRS clients the benefits of this partnership.

 

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=212 Fri, 08 Jan 2016 00:01:00 +0000
<![CDATA[Interoperability continues to define thinking at userBridge.15 conference]]>

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.

http://www.lorenz.cc/corporate/press-releases/press-release.cfm?ID=211 Mon, 05 Oct 2015 00:10:00 +0000