60 LORENZ Life Sciences News Feed List of all press releases issued by LORENZ. http://www.lorenz.cc <![CDATA[userBridge.19 in Athens, Greece from 17-19 September 2019: Save the date and register now!]]>

Frankfurt/Main, 14 June 2019 // The userBridge regulatory affairs conference hosted by LORENZ Life Sciences Group will take place in Athens, Greece from 17-19 September 2019. This annual gathering attracts and showcases the latest thinking in regulatory affairs, offering a range of perspectives from agencies, industry and prominent consultants. The event is also structured to allow generous time for one-on-one networking. Many participants return to this forum year after year, and newcomers always feel warmly welcomed.

This year’s conference venue will be the Divani Apollon Palace & Thalasso, one of Athens’ most iconic hotels. With the booking code 11195, userBridge participants can take advantage of a special room rate at the conference location, avoiding a daily trek to the event through the city’s heavy rush hour traffic.

 

 

Spread over 2½ days, userBridge offers its delegates both in-depth learning and the chance to exchange views with other regulatory affairs experts. In-depth plenary presentations are complemented by a wide range of other learning formats in small groups as well as on a one-on-one basis:

       • LORENZ ‘Meet to Talk’ gives people the chance to book a private 45-minute slot with one or more of the company’s senior
         executives.
       • Table Tutorial sessions allow the detailed exploration of specific topics in small groups.
       • The Agency Round Table enables participants to interact directly with agency representatives.

The conference agenda will cover a cross-section of current regulatory affairs issues, including:

       • Agency updates from Health Canada, US FDA and South African SAHPRA
       • Regional eSubmission updates on China, EAEU and GCC
       • DMF eCTD for US and Canada
       • Industry experience on automating submission process
       • Merging of standards - eCTD, IDMP and structured product data
       • Practical experience in preparing CP/MRP/DCP dossiers for Brexit
       • Latest developments in African Medicines Regulatory Harmonization
       • What's new in LORENZ products?
       • Best practice advice on processes, content and software

"The simultaneous profusion and merging of standards and the increasing ability to create seamless workflows between multiple regulatory systems is providing a huge opportunity in our sector,” notes Raoul Lorenz, CEO of the LORENZ Life Sciences Group, “and we’re proud that userBridge has become an important gathering for anyone who wants to keep up with the latest developments in regulatory affairs. We hope very much to see you in Athens this September.”

To register for LORENZ userBridge.19 on 17-19 September 2019 in Athens please click here!

To take advantage of the userBridge special room rate at the Divani Apollon Palace & Thalasso, use the booking code 11195 and follow this link!

 

About LORENZ
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 that enable compliance enforcement globally. LORENZ' 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 1050 paid installations in 38 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=241 Fri, 14 Jun 2019 00:06:00 +0000
<![CDATA[LORENZ and ERIS co-host successful eCTD workshop in Beijing]]>

Frankfurt/Main and Beijing, 12 June 2019 // LORENZ and ERIS recently co-hosted the successful “2019 China eCTD Management and Application Workshop” in Beijing. The event was designed to assist pharmaceutical companies in structuring their submission management processes to meet China’s upcoming eCTD requirements. Participants received comprehensive training in the relevant eCTD submission management regulations and expected practices for the Chinese market.

“We were extremely proud to have experts from the eCTD project team at CDE, NMPA on hand to meet our participants and to share the latest progress on the Chinese eCTD projects, including the technical specifications and verification standards,” says Jeremy Yi, CEO of ERIS, “and we also covered eCTD basics and current global trends.”

In addition to health authority participants, a range of invited industry representatives shared their valuable practical experiences in creating submission-ready documents and compiling eCTD submissions, as well as their insights into creating the necessary processes and teams, the use of related software, and many other aspects.

Experienced trainers from both China and Germany took workshop participants through the entire submission process including compiling, reviewing, and validating an eCTD submission, as well as handling the lifecycle management, all demonstrated while using the LORENZ docuBridge FIVE solution. This is the software that the CDE has chosen for their own eCTD validation, review and management.

“It was gratifying to see how well all participants interacted with our eCTD experts,” says Frank Schroer, Senior Trainer at LORENZ, “and we believe that thanks to these two days of training, the participating companies are now much better prepared to meet the eCTD submission requirements in China.”

 

 

The CDE issued the Chinese eCTD specification and validation criteria draft and related documents for public comments on March 1, 2019 (click here). In addition, the NMPA published the Chinese M1 requirements and a translated version of the CTD on April 17, 2019 (click here). Together, these mark an important milestone in China´s eCTD project, kicking off the final countdown to the implementation of eCTD submissions in China.

According to the experts at the workshop, the Chinese eCTD specifications and verification standards have now been closed for comments. The eCTD submission guidelines and implementation announcements are currently being drafted and will soon be ready for public comments.

From a corporate perspective, introducing eCTD submissions is a massive undertaking; much more than just a short-term task. It means setting up an eCTD submission management system, including adapting management processes to it, and establishing cooperation between the drug development and drug registration teams, as well as building up and training the eCTD submission management team and understanding the actual eCTD regulations. Each of these aspects will directly impact the efficiency of a company’s eCTD submission management, and influence how quickly a drug will be approved for marketing.

“With the help of our experts and trainers, participants have obtained a good understanding of these important interrelationships,” notes Fabian Witzel, Corporate Development Manager at LORENZ, “and at the same time, this workshop helped us to gain a better understanding of the needs of the Chinese industry. We are truly proud to be a part of the Chinese eCTD project, supporting both industry players and the agency in taking this important step forward.”

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. As a leading supplier of submission management systems for eCTDs, the solutions of LORENZ are geared towards industry, health authorities and academia that enable compliance enforcement globally. LORENZ' tried and tested solutions specifically cover submission assembly, review, publishing, validation and management. Furthermore, the company’s portfolio covers product registration/IDMP, regulatory planning and tracking products, as well as related services.

To date, LORENZ has established eCTD systems for 12 national health authorities, including the US FDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.

About ERIS
ERIS (www.eris-bj.com) focuses on electronic regulatory services. Based on the experience of providing registration regulatory and information services, ERIS is dedicated to providing the clients with the world's most desirable e-regulatory affairs solutions, as well as local installation, configuration, training, regulatory consultation, and post maintenance services, fully meeting clients’ needs in eCTD application management.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=240 Wed, 12 Jun 2019 00:06:00 +0000
<![CDATA[RIM Thought Leaders Converge, Connect and Collaborate at LORENZlink]]>

Frankfurt/Main, 23 April 2019 // New Orleans played host to this year’s LORENZlink, LORENZ' Regulatory Information Management Solutions Conference, which took place on April 9 and 10, 2019. The event, attended by industry and health authority experts, featured presentations and tutorials geared to answer key questions encountered in today’s RIM landscape.

A joint Keynote by Raoul Lorenz, Christian Kaas and Yaprak Eisinger from LORENZ was followed by presentations from leading regulatory professionals working at Accenture, Bayer, Biogen, Gilead, Novartis, Pharmatech Associates, QDossier and Whitsell Innovations. Industry expert Steve Gens shared key trends and predictions on RIM 2022, while Health Canada’s Irena Pastorekova gave an update on eCTD. The event also offered optional training opportunities in creating eCTDs as well as the basics of how the FDA reviews applications for those who opted to extend their stay.

 

 

There was also time carved out for networking and fun! Participants were part of a second line parade through the streets of the French Quarter bubbling with local culture as they made their way to dinner on the first evening. Other venues with jazz and blues music provided unique backdrops for LORENZ customers and partners to continue to share ideas and insights after hours.

“We look forward to the privilege of hosting LORENZlink in Vancouver next April,” said Yaprak Eisinger, Managing Director, North America for LORENZ. “Spotless execution of education, coupled with thoughtful and fun activities,” “…hit it out of the ballpark with LORENZlink 2019,” were some of many rewarding pieces of feedback that LORENZ will continue to strive after in coming years.

 

About LORENZ
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 that enable compliance enforcement globally. LORENZ' 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 1050 paid installations in 38 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=239 Tue, 23 Apr 2019 00:04:00 +0000
<![CDATA[Alliance of Experts: Your partner for an end-to-end RIM solution in Life Sciences]]>

Frankfurt/Main, Germany and Amersham, England and Sarasota, FL, 12 February 2019 // Generis, Phlexglobal and LORENZ Life Sciences Group, announce the founding of the Alliance of Experts, a new source for end-to-end Regulatory Information Management (RIM) and Clinical solutions in Life Sciences. The Alliance of Experts brings the expertise of each company together to provide seamless interoperability between their software packages, providing customers a ‘single source of truth’ for all data that can be used and applied in multiple solutions.

Prior to the founding of the Alliance of Experts, life science customers either employed a range of specialized tools from several different domain specialists to meet RIM requirements which may not work together or purchased a single solution RIM enterprise tool that provided limited depth of expertise in the rapidly changing life science market. The Alliance of Experts offers the best of both worlds by providing expert, established applications and guaranteeing the integrations between them with a single Alliance support service. This approach removes the burden of maintenance and risk from our customers, while ensuring zero compromise on functionality.

A prime example of an effective RIM solution provided by the Alliance of Experts is the Submission Archiving function. Leveraging the integration between LORENZ docuBridge and  Generis’ CARA, Submission Archiving pushes an archive copy of the published submission into CARA for long term storage, while creating an application sequence in docuBridge that includes leaf nodes pointing to the relevant files in CARA. Archived submissions can be accessed from CARA or from docuBridge with equal ease, giving customers exactly the same view of the submission that the agency has, along with links to the source files of their published equivalents.

“The whole point of the Alliance of Experts is efficiency,” says James Kelleher, CEO at Generis, “and this means that customers benefit directly from having a single source of regulatory data that can feed many different processes. This means that the sheer number of sources of error are greatly reduced.”  

Karen Roy, Chief Strategy Officer from Phlexglobal echoes the sentiment: “Combining our Clinical expertise with the Alliance’s Regulatory Affairs expertise really creates a whole new user experience. Customers can assemble their own perfect solution from a range of different partial ones.”

"The Alliance of Experts combines the advantages of a single RIM vendor and at the same time overcomes the limitations of a single RIM vendor," says Raoul Lorenz, CEO of LORENZ Life Sciences Group, "Through 'automated integration' we are taking the headache out of system integration, and are able to offer more variety and much deeper functionality. This is a marked step forward from both the classic approaches as well as the rigid platforms that have tried to replace them."

For more information of how the Alliance of Experts has created agile, tailored, end-to-end solutions to help customers, check out the joint initiative’s website.

About LORENZ

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 that enable compliance enforcement globally. LORENZ' 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 1050 paid installations in 38 countries, LORENZ has a strong worldwide customer base.

About Generis Knowledge Management

Generis has been providing leading-edge software for content management systems including Documentum, SharePoint, Alfresco and Oracle WebCenter since 1997.  The company has more than 50 customers across industries from Federal Government, through Life Sciences and Engineering to Media, Publishing and Financial.  The company is headquartered in Sarasota, FL, and has its principal development centers in Europe.  Customers include 8 of the global top 10 Life Science companies, Federal and State governments, engineering and media companies.  For more information about Generis visit  www.generiscorp.com.

About Phlexglobal

Phlexglobal are world renowned thought leaders and specialists in the provision of electronic Trial Master File (eTMF) systems and services. They offer a unique combination of eTMF technology with PhlexEview – their market leading eTMF system, quality services and specialist resource that delivers a range of flexible, targeted solutions to meet your business needs. Phlexglobal is headquartered in the UK, with offices in Malvern, PA and Lublin, Poland. 

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=238 Wed, 13 Feb 2019 00:02:00 +0000
<![CDATA[Register now for LORENZ' RIM Solutions Conference to be held in New Orleans, April 9-10, 2019]]>

Frankfurt/Main, 11 January 2019 // LORENZ’ annual Regulatory Information Management Solutions conference (LORENZlink) will take place at the Astor Crowne Plaza Hotel in the French Quarter of New Orleans, where Canal Street meets Bourbon Street. This annual conference attracts LORENZ customers, partners and other RIM professionals for two days of presentations, networking and exchange of ideas.

Established under the overall theme “Converge, Connect and Collaborate,” the conference covers a wide variety of presentations and tutorials focusing on practical solutions for current challenges regulatory and IT professionals face. Topics will include:

  • Synchronization of metadata attributes with master data in support of searches
  • Data import challenges and solutions
  • Managing Combination Products
  • Working with the eCTD format in global products
  • Updates on electronic submissions at Health Canada
  • Practical applications of artificial intelligence in regulatory writing and publishing 

Participants will also have an opportunity to explore in depth the full range of LORENZ products during the following discussions: What’s New in LORENZ docuBridge, Understanding LORENZ as a view Tool, Practical Solutions for LORENZ Automator and LORENZ drugTrack – Benefits and Business Cases.

LORENZlink also includes a range of table tutorials geared towards smaller groups of less than 25 people. These interactive group sessions will give participants the chance to dive into selected topics in depth, and discuss challenges that are relevant to them.

An optional product training day will follow on April 11, offering a choice between an advanced docuBridge FIVE training or a basic docuBridge ONE training. Both sessions will cover creating a new application (US version 3.3) and the basics of compiling modules 1 (regional information), 2, 3, 4 and 5 (STFs), as well as how the US FDA reviews applications.

“We are once again looking forward to welcoming a distinguished faculty of LORENZ customers, partners and staff as we learn from each other and plan for the future” said Yaprak Eisinger, Managing Director, North America, LORENZ Life Sciences Group. “We hope New Orleans will provide an unique backdrop with its distinctive blend of people, food, music and traditions.”

Click here to register now and save your space! 

For information on the conference and/or the additional training day, please contact:
Maria DeRose, mderose@lorenz.cc
Phone: +1 914 584 1955

 

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' 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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. 

  

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=237 Fri, 11 Jan 2019 00:01:00 +0000
<![CDATA[ERIS and LORENZ announce exclusive partnership agreement for China]]>

(Click here for Chinese version)

Frankfurt/Main and Beijing, 05 November 2018 // Beijing ERIS Information Technology Co, Ltd. ("ERIS") and the German LORENZ Life Sciences Group ("LORENZ") recently signed a cooperation agreement, officially designating ERIS as the exclusive agent and distributor for LORENZ e-regulatory affairs solutions in mainland China.

 

 

Under this new cooperation framework, ERIS will be responsible for the marketing, distribution, implementation and local maintenance of LORENZ docuBridge and eValidator. Small, medium and large companies as well as regulatory agencies use docuBridge to compile, publish, manage and review electronic submissions. The software generates submissions that comply with Chinese and global eCTD standards. NeeS, VNeeS, HTML, PDF, and paper formats are also supported. eValidator technically validates eCTD, NeeS, PDF and other submissions to verify and ensure compliance with the standards of health agencies in China and other countries. ERIS will be dedicated to provide the world's most desirable e-regulatory affairs solutions to domestic pharmaceutical companies, contract research and consulting companies, assisting clients in meeting China’s eCTD regulatory requirements, and improving the quality of eCTD applications. This process will help accelerate the approval and launch of their products.

ERIS is pleased to note that on July 02, 2018, Shanghai Baosight Software Co., Ltd. ("Baosight Software") was selected to establish an eCTD data management system for Chinese Center for Drug Evaluation, NMPA. LORENZ had entered into an agreement with Baosight Software to provide LORENZ’ docuBridge and eValidator as an eCTD review system, validation system and document management system required by CDE, as well as corresponding consulting and training services. ERIS will now assist LORENZ and Baosight Software in implementing the eCTD data management system for the CDE.

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ offers a wide array of Regulatory Information Management solutions geared towards industry, health authorities and academia in order to support compliance globally. LORENZ' tried and tested solutions cover product registration/IDMP, submission assembly, validation and management, publishing/eCTD, regulatory planning and tracking products, as well as related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow its customers to enhance their operational efficiencies. With over 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. The company headquarters is located in Frankfurt, Germany.

To date, LORENZ has established eCTD systems for 12 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.

About ERIS
ERIS (www.eris-bj.com) focuses on electronic regulatory services. Based on the experience of providing registration regulatory and information services, ERIS is dedicated to providing the clients with the world's most desirable e-regulatory affairs solutions, as well as local installation, configuration, training, regulatory consultation, and post maintenance services, fully meeting clients’ needs in eCTD application management.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=236 Mon, 05 Nov 2018 00:11:00 +0000
<![CDATA[LORENZ docuBridge and eValidator selected by the Chinese NMPA for an eCTD Data Management System]]>

(Click here for Chinese version)

Frankfurt/Main and Beijing, 02 November 2018 // On July 02, 2018, the Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) selected Shanghai Baosight Software Co., Ltd. in a tender to establish the eCTD data management system, and LORENZ was chosen by Baosight as software provider in this project.

To establish the eCTD data management system, LORENZ will provide docuBridge and eValidator as an eCTD review system, validation system, and document management system required by CDE, as well as corresponding consulting and training services.

The project is a milestone for all parties. Baosight Software and LORENZ are strongly committed to the CDE’s ambitious goal of implementing eCTD submissions as early as 2019.

Since joining the ranks of the ICH – the international body that sets the standards for harmonizing pharmaceutical registrations globally - in June 2017, China has been eager to adopt its standards. This move will widen access to China’s pharmaceuticals market for foreign companies while also enabling local producers to export regulated products much more easily. China’s ICH membership is what has triggered the speedy move to the eCTD format.

“LORENZ is truly proud to be supporting the acceleration of Chinese drug evaluation and approval system, and we aim to provide an integrated, world-class solution that suits the NMPA perfectly” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Together with Baosight Software, we’ll be using our global experience to ensure that the implementation of the eCTD format in China runs as smoothly as possible.”

 

About LORENZ
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ offers a wide array of Regulatory Information Management solutions geared towards industry, health authorities and academia in order to support compliance globally. LORENZ' tried and tested solutions cover product registration/IDMP, submission assembly, validation and management, publishing/eCTD, regulatory planning and tracking products, as well as related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow its customers to enhance their operational efficiencies. With over 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base. The company headquarters is located in Frankfurt, Germany.

To date, LORENZ has established eCTD systems for 12 national health authorities, including the USFDA (USA), EDQM (Europe), BfArM (Germany), Health Canada (Canada), TGA (Australia), and the Thai FDA (Thailand). It is currently assisting CDE, NMPA (China) in establishing its eCTD data management system.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=235 Fri, 02 Nov 2018 00:11:00 +0000
<![CDATA[userBridge.18 highlights need of semantical interoperability]]>

Frankfurt/Main, 01 October 2018 // LORENZ userBridge.18 in Prague was completely sold out once again this year, drawing more than 180 attendees from industry, consulting and regulatory health agencies around the globe. Hosted at the centrally-located Hotel Ambassador Zlata Husa from 18-20 September, the conference was packed with presentations, table tutorials and panel discussions covering current issues in the Regulatory Affairs sector, all in line with the userBridge motto:  “Learn – Discuss – Interact”.

The event kicked off with a LORENZ keynote presentation showcasing the company’s move to a shared business logic of its solutions using semantical interoperability within the LORENZ Foundation. Christian Kaas, Managing Director Research & Development at LORENZ, also gave live demonstrations of the company’s Regulatory Information Management (RIM) approach and Adam, its virtual regulatory NLP Assistant. The RIM topic was also echoed in many other userBridge presentations including “RIM – a single system or a happy family” and “RIM implementation and integration. Tailoring the evaluation for the right solution”. 

The wide range of userBridge presentations captured the spirit of the times. Prof. Sir Alasdair Breckenridge considered the possible implications of the Brexit on the Regulatory Affairs world. Presentations about IDMP and SPOR also gave participants a better understanding of these emerging trends in the sector.  

 

 

Many prominent Regulatory Affairs consultants and industry experts shared their insights with participants, including Remco Munnic of Asphalion, Elke Schydlo of Sandoz, and Dr. Andreas Franken of the German Medicines Manufacturers’ Association (BAH) among many others. Agencies were also well represented, including an update from Health Canada by Vianney Caron and a presentation from Dr. Klaus Menges of the German authority BfArM.
 
A selection of 24 different table tutorials – small-scale learning and Q&A sessions on specific topics – gave attendees the chance to pick and choose several sessions. The bandwidth of tutorials ranged from LORENZ product news such as “LORENZ Automator: Do you know Adam?” and “What´s new in LORENZ docuBridge?” to more broad Regulatory Affairs topics such as eCTD 4.0 and getting submissions ready.
 
In the breaks between the presentations and tutorials, participants had plenty of time to network with LORENZ representatives and other colleagues in the Regulatory Affairs arena. During the evening events, after the presentations, they also had time to talk in a more open way. This way, LORENZ offered an environment perfectly made to learn, discuss and interact with colleagues outside of the daily routine. 
 
“We always feel honoured that so many Regulatory Affairs experts with such diverse backgrounds all make a point of attending userBridge, year after year,” noted Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, “and we’re very happy to provide this kind of forum for leading edge thinking in the sector.”  
 

About LORENZ
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' 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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=233 Mon, 01 Oct 2018 00:10:00 +0000
<![CDATA[Otsuka selects LORENZ docuBridge to manage eSubmissions worldwide]]>

Tokyo and Frankfurt/Main, 01 October 2018 // The Otsuka Pharmaceutical Co., Ltd., a Japan-based holistic healthcare company, has chosen LORENZ’s docuBridge as their global eSubmission management system. The docuBridge solution will be adapted to support Otsuka’s operations in Japan, the EU, the USA, Canada, as well as its affiliates Taiho Pharmaceutical, Taiho Oncology, Astex Pharmaceuticals, and Avanir Pharmaceuticals.

"We are very pleased to award Otsuka’s next generation global publishing platform to LORENZ. The detailed product evaluation by our global team unanimously recommended docuBridge as solution of our choice for its usability, sequence management that supports global submissions, and expanding use by regulatory authorities as their viewer and validation solution.” says Kenji Nagamura, a senior member and sponsor of the product evaluation team at Otsuka.  

“LORENZ would like to congratulate Otsuka for selecting the most advanced solution available in today’s marketplace. We’re gratified by their decision, and are collaborating closely to ensure a successful global implementation,” says Wolfgang Witzel, President of LORENZ Life Sciences Group. “Our docuBridge solution will ensure that Otsuka can efficiently meet the constantly evolving Regulatory requirements across all markets.”

“We are very happy to partner with LORENZ to support Otsuka in adapting docuBridge to the specific needs of Otsuka in Japanese region,” says Hiroji Emoto, President and CEO of Digital Media System Co., Ltd., the exclusive distributor for docuBridge in Japan. “This solution will greatly increase the productivity in managing the eSubmissions around the globe – and contributing to Otsuka’s mission of improving and supporting the health of people.”

LORENZ docuBridge is the most advanced multi-user eSubmission production and management system for small, medium and large companies as well as regulatory agencies to compile, publish, manage and review electronic submissions. docuBridge complies with all global eCTD standards, NeeS, VNeeS, paper submissions and more. The solution was also recently selected by the USFDA as part of its RIM portfolio. 


About Otsuka
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical at www.otsuka.co.jp/en/

About DMS (Digital Media System Co., Ltd.)
DMS has been a LORENZ partner since 2004 and has actively been involved in developing the Japanese eCTD market for the LORENZ docuBridge Submission Management System software. DMS has been instrumental in aiding in the development of the Japanese language module and continues to provide local support, training, installation and validation to LORENZ’ Japanese customers. DMS has been providing a Japanese eCTD Compilation Service using LORENZ docuBridge since 2006. In close collaboration with local partners, DMS has been further developing and tailoring the product for Japanese pharmaceutical manufacturing and marketing approvals. DMS pioneered the Japanese regulatory affairs market by laying the groundwork for the first ever original eCTD submitted to the Japanese PMDA by Chugai Pharmaceutical Co., Ltd. in 2005.

About LORENZ
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 950 paid installations in 36 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=234 Mon, 01 Oct 2018 00:10:00 +0000
<![CDATA[userBridge 2018 in Prague - The countdown has started!]]>

Frankfurt/Main, 17 May 2018 // The countdown to the LORENZ userBridge 2018 conference has begun! In just 18 weeks, industry and authority professionals from around the globe will gather in Prague to discuss current challenges and solutions in the world of e-regulatory affairs. This two-and-a-half day event hosted by LORENZ Life Sciences Group runs from the 18th to the 20th of September 2018, and will include a range of expert presentations designed to give participants useful new insights into current issues.

In addition to the speaker presentations, userBridge will once again offer a wide selection of table tutorials; small group discussions that each focus on a single issue. These sessions offer the chance to ask questions, get answers and understand how others have solved similar issues. Participants can sign up for table tutorials, selecting whichever topics are most fitting.

All presentations and table tutorials relate to key issues in regulatory affairs, and will cover most of them from both industry and agency perspectives:
         • Regulatory specifications
         • Regulatory strategy
         • Industry processes
         • Agency processes
         • IT in regulatory affairs

The entire conference is built around the motto ‘’learn, discuss and interact’’; giving participants the chance to network, exchange experiences and reach a deeper understanding of complex topics. The event will take place against the backdrop of Prague, the Czech Republic’s lovely capital.

Please click here to register for LORENZ userBridge.18 conference on 18th – 20th of September in Prague!

About LORENZ
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' 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 900 paid installations in 35 countries, LORENZ has a strong worldwide customer base.

http://www.lorenz.cc/about/press-releases/press-release.cfm?ID=232 Thu, 17 May 2018 00:05:00 +0000