Lorenz Events

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? Perhaps you’ve heard this new term being thrown around as a new feature in LORENZ docuBridge. Regulatory Content Management is an enhancement on docuBridge’s Content Management capabilities and is available for docuBridge FIVE. In this tutorial, Adam Burgess will explain the purpose of RCM, including how it can help your Regulatory Processes, and provide participants with an opportunity to go through some example use-cases.
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Assisted compilation updates – Automatic sequence compilation
Kent Briggs, VECTOR Life Sciences

Assisted compilation updates – Automatic sequence compilation
Kent Briggs, VECTOR Life Sciences

Assisted compilation allows you to automatically compile sequences with a click of a button. Implemented in 2019 and integrated into the Best Practice Configuration in 2021, assisted compilation has been expanded to support most of the eCTD regions and both Study Tagging File (STF) and Non-STF study compilation requirements. Recent updates have added, among others, the new South African 3.1, ECOWAS 1.0, and the EAEU. We will highlight the supported regions, the functionality, and any requirements for updating any existing Assisted Compilation setup or for adding Assisted Compilation for the first time.
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Panel discussion on eCTD v4.0
Yuki Terauchi, Chugai Pharmaceuticals, Hiroji Emoto, Digital Media System Co., Ltd., & Dr. Andreas Franken, Pharma Deutschland e.V., Dr. Bernd Misselwitz, Bayer AG & Tim Powell, Biogen Idec Limited

Panel discussion on eCTD v4.0
Yuki Terauchi, Chugai Pharmaceuticals, Hiroji Emoto, Digital Media System Co., Ltd., & Dr. Andreas Franken, Pharma Deutschland e.V., Dr. Bernd Misselwitz, Bayer AG & Tim Powell, Biogen Idec Limited

Join us for a dynamic panel discussion delving into the future of the eCTD format, with a particular focus on eCTD v4.0. Our expert panelists will explore the evolution of eCTD standards, the impact of eCTD v4.0 on regulatory submissions, and the implications for pharmaceutical companies and regulatory agencies. Gain valuable insights into the potential benefits, challenges, and best practices associated with adopting the latest eCTD version. Stay ahead of the curve in our changing landscape.
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eCTD & IDMP – ICH meets ISO
Dr. Andreas Franken, Pharma Deutschland e.V.

eCTD & IDMP – ICH meets ISO
Dr. Andreas Franken, Pharma Deutschland e.V.

In today's digital world, where data availability and processing are crucial for the success of businesses and research institutions, the need to efficiently structure and exchange information is becoming increasingly urgent. This session highlights the advantages of submitting structured data compared to traditional PDF documents. While PDFs are often seen as a universal format for documentation, structured data formats such as JSON, XML, or FHIR offer significant benefits in terms of interoperability, machine learning, and data analysis. We will discuss their advantages and the limitations of PDF, particularly regarding the automation of data processing and integration into modern data ecosystems.
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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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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

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
- How the LORENZ dashboards could support you today
- How the LORENZ dashboard could be enhanced for the future
Attendees will be able to engage, learn, and provide suggestions for product improvements.
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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 partie
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Get rid of your Excel sheets - Optimizing the data migration process
Benjamin Honold, InfectoPharm Arzneimittel und Consilium GmbH

Get rid of your Excel sheets - Optimizing the data migration process
Benjamin Honold, InfectoPharm Arzneimittel und Consilium GmbH

In August 2022, InfectoPharm launched a project to transfer the regulatory core data from several Excel sheets to a “single source of truth” - a validated RIM solution. In this table tutorial, we would like to take a closer look at the lessons learned from the implementation phase of the last months and the challenges of transferring and cleansing the data from a customer perspective.
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What you didn’t know your rendering platform can do for you…
Paul Ireland, DocShifter

What you didn’t know your rendering platform can do for you…
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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Types of submissions in the EU and their lifecycles
Dr. Michael Jandke, External Expert

Types of submissions in the EU and their lifecycles
Dr. Michael Jandke, External Expert

To market a medicinal product in the EU, obtaining a marketing authorization is essential. This requires the submission of numerous documents, each specific to the chosen approval route. This tutorial provides a high-level overview of the most common, yet distinct registration processes within the EU. It covers the timelines and procedural steps of the Mutual Recognition (MRP), Decentralized (DCP), and Centralized (CP) procedures. Additionally, you will gain deeper insight into the pre- and post-procedural steps of the Centralized Procedure. Immerse yourself in the diverse regulatory submission strategies in the EU! A special focus will be placed on the product class of personalized medicine, including cell therapeutics, tissue-engineered products, and gene therapeutics.
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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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Future release & validation strategy
Leonhard Kelller and & Manuel Stein, LORENZ Life Sciences Group

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 v4.0
Jessica Lemley, LORENZ Life Sciences Group

A vital conversation on embracing and enhancing eCTD v4.0
A vital conversation on embracing and enhancing eCTD v4.0

Let’s chat and discuss the dynamic environment of eCTD v4.0. In this table tutorial we will cover where we currently are in the vast landscape of eCTD v4.0 for the US and take a glimpse into where and when the rest of the world will embrace v4.0.
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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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Harmonization in Africa through eCTD and reliance
Mariam Aounallah, ANMPS, Sybil Nana Ama Ossei-Agyeman-Yeboah, ECOWAS, Abayomi Akinyemi, NAFDAC, Don Lebitsa & Madelein Terblanche, VECTOR Life Sciences

Harmonization in Africa through eCTD and reliance
Mariam Aounallah, ANMPS, Sybil Nana Ama Ossei-Agyeman-Yeboah, ECOWAS, Abayomi Akinyemi, NAFDAC, Don Lebitsa & Madelein Terblanche, VECTOR Life Sciences

The use of eCTD in Africa for harmonisation through reliance mechanisms represents a significant stride towards improving regulatory efficiencies, enhancing access to quality medicines, and fostering regional integration. This session explores the current landscape, challenges, and opportunities in the implementation of eCTD in Africa, emphasizing the critical role of reliance strategies in achieving harmonisation. Inclusion of a standardised eCTD specification in collaborative initiatives like ECOWAS and the AMA pilot project, the potential for a harmonised regulatory environment in Africa that ensures timely access to safe and effective medicines is underscored.
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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

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

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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LORENZ Keynote
Raoul-A. Lorenz, Lorelle Leonienco, Anna Kispál & Patrick Kunkel, LORENZ Life Sciences Group

Update on eCTD v4.0 implementation and outlook into the evolution of eCTD
Dr. Bernd Misselwitz, Bayer AG & Tim Powell, Biogen Idec Limited

Update on eCTD v4.0 implementation and outlook into the evolution of eCTD
Dr. Bernd Misselwitz, Bayer AG & Tim Powell, Biogen Idec Limited

The eCTD v4.0 implementation train is running and its gaining speed. With this presentation we would like to provide the latest updates on the regional implementation plans and timelines from an ICH M8 and Industry perspective. In addition, we want to share with you the latest reflections on the potential future of eCTD, including current thoughts on how the standard could evolve to become more data centric and incorporate new technologies such as shared environments. We will discuss challenges, opportunities and potential next steps for the eCTD Evolution.
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How to streamline your reviewing process with LORENZ docuBridge
Maximilian Muth, LORENZ Life Sciences Group

How to streamline your reviewing process with LORENZ docuBridge
Maximilian Muth, LORENZ Life Sciences Group

Reviewing your sequence can involve a lot of work and effort. In this table tutorial, we will show you how to effectively review your soon-to-be-finished sequences, including all the features of docuBridge like the enhanced comments function and the new notification center of dB 24.1
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What’s new in LORENZ docuBridge
Chithra Muthukrishnan, LORENZ Life Sciences Group

What’s new in LORENZ docuBridge
Chithra Muthukrishnan, LORENZ Life Sciences Group

This table tutorial will focus on the updates and new features reflected in LORENZ docuBridge 24.1. This table tutorial will go through each new feature and include a demo of User Notifications for Note Replies and Note Status Changes, New Searches for Sequence and Document Favourites, and the Compare Documents Feature in Web Access, as well as many other exciting new features.
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LORENZ RIM Solution for capturing product information in IDMP/XEVMPD formats, management of eCTD submissions to registration tracking
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

LORENZ RIM Solution for capturing product information in IDMP/XEVMPD formats, management of eCTD submissions to registration tracking
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

In this tutorial, participants will have the opportunity to learn how to get most out of our standard LORENZ RIM Solution. Without customization, we will demonstrate how our out-of-the-box solution easily captures structured product information in IDMP/XEVMPD formats and manages your eCTD submissions to agencies. Experience how our standard “Product information and lifecycle management” capability can be used to track all submissions to Health Authorities – from initial and subsequent submissions of eCTD sequences to final approval by the agency; and simultaneously update your medicinal product information via the agency’s gateway directly.
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Search Management and dashboards for LORENZ RIM Solution with single and multiple capabilities
Dr. Grace Ng-Kruelle & Chithra Muthukrishnan, LORENZ Life Sciences Group

Search Management and dashboards for LORENZ RIM Solution with single and multiple capabilities
Dr. Grace Ng-Kruelle & Chithra Muthukrishnan, LORENZ Life Sciences Group

In this table tutorial, we will explore how to create an Advanced Search, customize your layout exclusively for Searches, and utilize it to personalize your Dashboard. We will explore how to assign access and permissions for your searches to users belonging to different groups within docuBridge. Additionally, you can leverage these permissions to create customized statistics and enhance your Dashboard experience. As part of our LORENZ RIM solution, we’ll wrap up the session by demonstrating how you can extend the Dashboard functionality to incorporate additional regulatory tracking information.
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Data driven submissions
Kevin O'Leary, Dassault Systemes

Data Driven Submissions
Kevin O'Leary, Dassault Systemes

This session will address the latest capabilities in delivering eCTD content directly from the source data by leveraging Structured Content Authoring with embedded Live Data Links to ensure content accuracy and the ability to refresh content as needed. This next gen approach is essential for achieving long-term Data Driven submissions (FHIR, PQ/CMC) for the industry in parallel with PDF targets.
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Collaboration as a global service partner on a central global docuBridge Submission Management System
Timm Pauli, Cencora PharmaLex

Collaboration as a global service partner on a central global docuBridge Submission Management System
Timm Pauli, Cencora PharmaLex

As a global service provider for electronic submissions, we – and our clients – heavily depend on a globally centralized eCTD submission management system. Nevertheless, the needs for a service provider differs significantly from those of a marketing authorization holder. This session will explain how docuBridge plays a key role for Cencora PharmaLex’ eSubmission service.
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Update on PRISM
Vada A. Perkins, Boehringer Ingelheim Pharmaceuticals, Inc.

Race to be the first with LORENZ docuBridge POC
Krzysztof Rowiński, Valneva Austria GmbH

Race to be the first with LORENZ docuBridge POC
Krzysztof Rowiński, Valneva Austria GmbH

In 2022, Valneva, a specialty vaccine company, was preparing for the BLA of its chikungunya vaccine. At the same time, the company was performing a tender to update the DMS and eCTD submission systems. This presentation shows how the docuBridge’s Proof of Concept approach enabled the smooth transition to the new system and the submissions to the regulatory agencies.
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What happens to my submission after dispatch to the agency?- An insight into the automated submission intake process
Dr. Katharina Schmitz, LORENZ Life Sciences Group

What happens to my submission after dispatch to the agency?-An insight into the automated submission intake process
Dr. Katharina Schmitz, LORENZ Life Sciences Group

Over the past years, LORENZ has provided multiple agencies with automation solutions that simplify their submission intake process. These solutions also benefit sponsors through a quicker and more harmonized intake process. In this table tutorial, we will give an overview of our standardized submission intake solution, but also point out differences between agencies and regions and provide some tips on what you can do to guarantee a smooth submission process.
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Trusted Regulatory Spaces in the cloud - Guiding principles
Omar Serang, DNAnexus, Inc.

Trusted Regulatory Spaces in the cloud - Guiding principles
Omar Serang, DNAnexus, Inc.

We are entering a new era of interactive review practices, with sponsor and health agency interactions occurring even before the official eCTD filing. Modern technologies and cloud platforms will enable these practices, and we must consider the foundational principles that will act as pillars of success. Join Omar Serang, Chief Cloud Officer at DNAnexus and Lead Architect of precisionFDA, as he explores these principles through key learnings from proof-of-concept projects, and how they will support the transition phases of eCTD today and in the future.
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Successfully implementing LORENZ docuBridge FIVE
Thomas Smith, Icon PLC

Successfully implementing LORENZ docuBridge FIVE
Thomas Smith, Icon PLC

Implementing or transitioning to a new publishing tool is major project for any organization, its far more than a software role out. During this table tutorial we will discuss points to consider prior to transition; how to manage the transition with no/minimal business disruption and ensuring the organization is equipped post transition to ensure a successful migration.
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Unleash drugTrack – About the (almost) endless possibilities of personalizing drugTrack
Matthias Spiller, LORENZ Life Sciences Group

Unleash drugTrack – About the (almost) endless possibilities of personalizing drugTrack
Matthias Spiller, LORENZ Life Sciences Group

We are entering a new era of interactive review practices, with sponsor and health agency interactions occurring even before the official eCTD filing. Modern technologies and cloud platforms will enable these practices, and we must consider the foundational principles that will act as pillars of success.
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AI powered eCTD submission process
Rainer Schwarz, KlearDoc / LORENZ Life Sciences Group & Anna Kispál, LORENZ Life Sciences Group

AI powered eCTD submission process
Rainer Schwarz, KlearDoc / LORENZ Life Sciences Group & Anna Kispál, LORENZ Life Sciences Group

We are pleased to showcase an exploratory prototype of an AI-integrated submission process for eCTD by LORENZ. By combining technical compliance validation with AI-powered content checks, we ensure the technical accuracy of eCTD submissions while semi-automating the creation and consistency validation of document content. This approach aims to significantly reduce review cycles, enhance compliance, and substantially elevate submission quality.
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eCTD v4.0 in Japan – History, special requirements and current activities
Yuki Terauchi, Chugai Pharmaceuticals & Hiroji Emoto, Digital Media System Co., Ltd.

eCTD v4.0 in Japan – History, special requirements and current activities
Yuki Terauchi, Chugai Pharmaceuticals & Hiroji Emoto, Digital Media System Co., Ltd.

In April 2022, eCTD v4.0 was officially accepted in Japan as an optional filing format in addition to eCTDv3.2.2. Today, several eCTD v4.0 applications have been submitted to the PMDA. It is expected that in April 2026 eCTD v4.0 will become the single mandatory submission format.This presentation covers the results of the eCTD v4.0 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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Best validation practices for LORENZ RIMS
Sandra Weniger-Niederberger & Riad Beqiri, Qudits AG

Best validation practices for LORENZ RIMS
Sandra Weniger-Niederberger & Riad Beqiri, Qudits AG

Dive into essential validation practices to ensure regulatory success. This session covers strategies for smart and audit-proof validation of LORENZ RIMS solutions. It offers insights on enhancing GxP compliance, data integrity, and workflow performance from start to finish. Ideal for newcomers and professionals, this is the perfect opportunity to ask questions and get answers tailored to your needs.
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