Lorenz Events

Using LORENZ docuBridge to accelerate global filings
Kehinde Bakin, Novavax, Inc., Kateřina Anna Klegová & Lucie Svobodova, Novavax CZ

Using LORENZ docuBridge to accelerate global filings
Kehinde Bakin, Novavax, Inc.& Kateřina Anna Klegová & Lucie Svobodova, Novavax CZ

LORENZ docuBridge offers advanced features that enable it to accelerate global filings: The ability to compile once and clone or publish in different formats was critical to Novavax’s success during the COVID-19 pandemic. One of the capabilities is the cloning functionality. Cloning adds efficiency to remove re-work or duplicate effort. The cloning method gives an organization the capability to submit to multiple countries in a shorter time and aim for faster Health Authority approvals. Although there are many publishing tools in the market, LORENZ docuBridge’s cloning features make the process easier and faster.
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Collaboration with multiple service partners on one global docuBridge Submission Management System
Dr. Dietmar Böcker, Bayer AG Pharmaceuticals

Collaboration with multiple service partners on one global docuBridge Submission Management System
Dr. Dietmar Böcker, Bayer AG Pharmaceuticals

The move to cloud technologies for regulatory submissions marks a significant shift in the utilization of regulatory information and submission management systems. This transition is driven by the need for more efficient and streamlined processes, as well as the increasing reliance on digital platforms. This presentation will explore the points to consider when collaborating with multiple service partners for regulatory submission management while leveraging docuBridge in a cloud environment.
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Regulatory Content Management with LORENZ docuBridge
Adam Burgess, LORENZ Life Sciences Group

Regulatory Content Management with LORENZ docuBridge
Adam Burgess, LORENZ Life Sciences Group

What is RCM (Regulatory Content Management)? Perhaps you’ve heard this new term being thrown around as a new feature in LORENZ docuBridge. RCM is an enhancement on docuBridge’s Content Management capabilities and is available for docuBridge FIVE. This tutorial will explain the purpose of RCM and how it can help your Regulatory Processes by providing you with some example use-cases.
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eCTD 4.0 in Japan – History, special requirements and current activities
Hiroji Emoto, Digital Media System Co., Ltd.& Yuki Terauchi, Chugai Pharmaceuticals

eCTD 4.0 in Japan – History, special requirements and current activities
Hiroji Emoto, Digital Media System Co., Ltd.& Yuki Terauchi, Chugai Pharmaceuticals

In April 2022, eCTDv4.0 was officially accepted in Japan as an optional filing format in addition to eCTDv3.2.2. Today, several eCTDv4.0 applications have been submitted to the PMDA. It is expected that in April 2026 eCTDv4.0 will become the single mandatory submission format. This presentation covers the results of the eCTDv4.0 pilot in Japan, the specifics when applying for eCTD v4.0 in Japan, and Chugai's practical experience with actual filing. Chugai Pharmaceutical Co., Ltd. has already processed many eCTD v4.0 submissions and is one of the most experienced companies in Japan.
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eCTD evolution und EU eCTD 4.0 Implementation Guide
Dr. Andreas Franken, Pharma Deutschland e.V.

How are regulatory organizations improving their effectiveness through the use of metrics driven continuous improvement?
Steve Gens, Gens & Associates

How are regulatory organizations improving their effectiveness through the use of metrics driven continuous improvement?
Steve Gens, Gens & Associates

This talk is based on the Gens & Associates World Class RIM studies that track 70+ companies on how they are getting better performance from the combination of an effective metric/KPI program and adopting a continuous improvement approach. Steve will show the accelerating adoption (via the benchmark data) of a business excellence department within Regulatory Operations and what specific metrics are being tracked. He will also review a metrics program maturity model and considerations for companies to improve how they track and communicate vital regulatory metrics. Part of this talk will also provide a quick snapshot of priority Regulatory investments in Strategic Health Authority Initiatives and the pace of Regulatory Digitization from the June 2024 World Class RIM study.
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Future distribution of LORENZ software
Martin Gutt & Christian Rachor, LORENZ Life Sciences Group

Future distribution of LORENZ software
Martin Gutt, LORENZ Life Sciences Group

It has become evident that our current distribution and deployment approach for our software products needs a significant overhaul to meet the evolving needs of our cloud hosting and our customers and to ensure a seamless installation experience. This tutorial will give you a first insight into the considerations and implementation of our future deployment strategies. In addition to the overarching idea, the practical implementation of the automated approach to deployment is also shown. Target Group: IT Admins and any interested parties
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Did you know your rendering platform can do…
Paul Ireland, DocShifter

Did you know your rendering platform can do…
Paul Ireland, DocShifter

As the regulatory world modernizes, so too does the technology that supports our everyday working lives. This table tutorial focuses on how the rendering technology available in LORENZ docuBridge can be used to automate many other manual and time-consuming tasks for content preparation, beyond just converting to PDF. Learn how many content preparation steps can be fully automated through the simple setup of technology you already possess today, allowing you to achieve and validate content compliance much earlier in your submission process.
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Clear up the mess! Migrate data into LORENZ drugTrack
Dr. Andreas Jahn & Artur Titkov, LORENZ Life Sciences Group

Clear up the mess! Migrate data into LORENZ drugTrack
Dr. Andreas Jahn & Artur Titkov, LORENZ Life Sciences Group

You might have another system or Excel sheets to track your regulatory data already in place, but how can you bring this information into LORENZ RIM? This table tutorial will show you show we can help you to bring your data into the Product Information and Tracking Tool drugTrack.
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LORENZ Business Configuration: Introduction & Outlook
Jan Kairies, LORENZ Life Sciences Group

LORENZ Business Configuration: Introduction & Outlook
Jan Kairies, LORENZ Life Sciences Group

This table tutorial will give an overview of our current configuration options and offers for docuBridge. We will talk about UI customization, workflow optimization with permission management as well as metadata and its processing. We will also look at the integration of currently supported CMS and provide an outlook on configuration options and offers to come, such as cross-functional usage of CVs and our RIM Best Practice Configuration.
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Compiling at H. Lundbeck A/S – A case study
Maria Kolding, H. Lundbeck A/S

Compiling at H. Lundbeck A/S – A case studyMaria Kolding, H. Lundbeck A/S

This presentation discusses the challenges associated with managing compiling tasks within the EU/ROW and sprinkled with stakeholders with differing levels of eCTD expertise.
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A vital conversation on embracing and enhancing eCTD 4.0
Jessica Lemley, LORENZ Life Sciences Group

A vital conversation on embracing and enhancing eCTD 4.0
Jessica Lemley, LORENZ Life Sciences Group

Let’s chat and discuss the dynamic environment of eCTD 4.0. In this table tutorial we will cover where we currently are in the vast landscape of eCTD 4.0 for the US and take a glimpse into where and when the rest of the world will embrace 4.0.
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Do you want to save time and minimize manual effort when reusing content in LORENZ docuBridge?
Sonia Lepkowitz, LORENZ Life Sciences Group

Do you want to save time and minimize manual effort when reusing content in LORENZ docuBridge?Sonia Lepkowitz, LORENZ Life Sciences Group

This table tutorial provides various approaches on how to work more efficiently when reusing documents, submissions, nodes, or searches. Consequently, you can ensure compliance and reduce the risk of errors.
We invite you to use this session as an opportunity to share your experiences and questions.
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Improving your RIM metrics & KPIs leveraging the LORENZ dashboards
Steve Gens, Gens & Associates & Lorelle Leonienco,
LORENZ Life Sciences Group

Improving your RIM metrics & KPIs leveraging the LORENZ dashboards
Steve Gens, Gens & Associates & Lorelle Leonienco,
LORENZ Life Sciences Group

Meaningful business metrics and KPIs are essential for measuring performance, setting goals, and driving strategic decisions. They provide clear, quantifiable metrics that help organizations track progress, identify areas for improvement, and ensure alignment with overall business objectives. This session will explore: Key insights on metric programs & KPI’s from the Gens & Associates 2024 World Class RIM Research

Mastering the challenges of PMS updates via XEVMP – Getting SPOR ready for ESMP and beyond
Karl-Heinz Loebel, Cencora PharmaLex & Patrick Kunkel,
LORENZ Life Sciences Group

In this table tutorial, we will discuss and demonstrate the XEVMPD data reviews, changes and enhancements expected from companies by the EMA this year to prepare their PMS product data for use in the European Shortage Monitoring Platform and PLM-eAF Portal. Learn how the Lorenz PI Viewer can help to display and analyze a company's XEVMPD portfolio in an efficient and convenient way.
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