Lorenz Events

Future in the Cloud
Dr. Shakthi Kumar, Amazon Web Services

Future in the Cloud
Dr. Shakthi Kumar, Amazon Web Services

“Cloud” is rapidly becoming the underlying platform for digital transformation and is transforming the Life Sciences landscape, especially in critical areas such as regulatory review and submission. Cloud-based regulatory platforms have evolved tremendously in the last few years with an emphasis on increased transparency of data sets and scientific information, closer coordination of regulatory pathways, more optimized workflow reviews, and faster submission. This session will provide insights on prevailing market trends, critical success factors, data security, and collaboration tools for next generation regulatory platforms.
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Digital Transformation – A Journey Towards a Data Driven Organization
Dorian Tisdale, Janssen Pharmaceutical Companies of Johnson & Johnson

Digital Transformation – A Journey Towards a Data Driven Organization
Dorian Tisdale, Janssen Pharmaceutical Companies of Johnson & Johnson

Digital Transformation is the latest and greatest thing in our industry, but it sounds easier than those two words make it seem. In this presentation, I will discuss the challenges we encounter along the way and show how this is a long term improvement project that will require a change in how we view projects, our data and how we go beyond storing large datasets with no value to a shift towards making data driven decisions.
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Enhancing Local Affiliate Engagement for Efficient Global RIM Programs
Steve Gens, Gens & Associates 

Enhancing Local Affiliate Engagement for Efficient Global RIM Programs
Steve Gens, Gens & Associates

This session will review findings from the latest Gens & Associates regulatory research (summer 2023) from over 300 local affiliate offices, aiming to improve the global management of regulatory data. We will 1) provide key insights by affiliate size and 2) consider study data by region. Topics include submission planning, registration, health authority interactions, label management, and more.
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Regulatory and Scientific Collaboration via Cloud Platforms
Vada A. Perkins, Bayer Pharmaceuticals

Regulatory and Scientific Collaboration via Cloud Platforms
Vada A. Perkins, Bayer Pharmaceuticals

The session will provide an overview of Project PRISM (PrecisionFDA Regulatory Information Service Module). Project PRISM is a Joint FDA/Industry Research Collaborative to demonstrate the feasibility of interactive/collaborative regulatory review and submission validation utilizing FDA’s production regulatory cloud platform, known as PrecisionFDA. The project will utilize actual regulatory grade data to be provided by PRISM Industry partners for submission to FDA, as well as third-party tools FDA currently uses for eCTD and study data review / validation. Use of PrecisionFDA will allow FDA and Industry collaborators an understanding of the benefits of a production regulatory cloud with the intent of informing future solutions. In addition, the project will provide valuable insight on both necessary and desired technical features and capabilities for more efficient regional and international regulatory assessment.
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docuBridge & Veeva: From a Company's Regulatory Need for Global Products to Health Authority Submissions
Dr. Max Nattermann, Bayer AG

docuBridge & Veeva: From a Company's Regulatory Need for Global Products to Health Authority Submissions
Dr. Max Nattermann, Bayer AG

Recently, Bayer has re-designed its regulatory affairs process and system landscape by implementing a Veeva Vault RIM platform with a strong connection to docuBridge. This talk is about strategies and challenges on our journey toward a seamless integration between the systems to transfer documents and dossier structures and to archive the published output for fulfilling global HA requirements.
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Stop Emailing Me, Annotate Me Instead…Using Annotation Feature for Submission Review
Rachelle Butt, United Therapeutics Corporation

Stop Emailing Me, Annotate Me Instead…Using Annotation Feature for Submission Review
Rachelle Butt, United Therapeutics Corporation

This session will demonstrate how the updated annotation feature in docBridge 22.2 can streamline the QC process. Currently, we often have multiple e-mail chains with various folks who need to review a submission, and using e-mails to address comments can be a challenge. With version 22.2, Regulatory Affairs can add comments to the submission itself, where Publishers can easily respond to them.
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eCTD and Electronic Submissions in Africa
Kent Briggs, VECTOR Life Sciences

eCTD and Electronic Submissions in Africa
Kent Briggs, VECTOR Life Sciences

The path to structured applications has been a long journey and continues to create its own path in Africa. With portals sprouting up in various countries and regions, one would think that structured content was well defined and guidance was plentiful. We will look at the progress Africa has made, the options available, the direction we are going in and the expected activities in the coming year.
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Health Canada Updates
Tracy Brown, Health Canada

Health Canada Updates
Tracy Brown, Health Canada

This session provides an update on Health Canada’s electronic submission policy, including regulatory enrolment process (REP) and use of the gateway. With the adoption and expansion of the use of XML files, Health Canada is continuing to move towards its goal of having a ‘Common Submission Intake’ process, where submissions/transactions in electronic format are received via the gateway, automatically validated and imported to docuBridge. In addition, Health Canada provides updates on the Product Monograph in XML format process, guidance and the timelines.
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Exploring Hidden Gems in docuBridge
Hilary Hafeken, Roivant Sciences, Ltd. 

Exploring Hidden Gems in docuBridge
Hilary Hafeken, Roivant Sciences, Ltd. 

Even if you’ve been using docuBridge for years, it can be sprawling and complex. There might be some helpful features you’re not using. In this session you’ll hear about Hilary’s 'Favorite Features', such as what Content Catalog is and how it can help you. You’ll also have the opportunity to share your own favorite features and learn how to complete publishing tasks faster and more efficiently.
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docuBridge userGroup
Philip Hall, DH Consultants

docuBridge userGroup
Philip Hall, DH Consultants

Find out about the docuBridge userGroup, how it was created, our growing membership, and the topics covered at our monthly meetings. These include using docuBridge effectively, understanding and interpreting certain agency guidelines, and insights from our multiple specialist groups. We will also discuss helpful aids like the “docuBridge for Dummies” booklet with helpful hints and tips for users.
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How Modern Rendering Can Automate Beyond the Creation of PDFs
Paul Ireland, DocShifter

How Modern Rendering Can Automate Beyond the Creation of PDFs
Paul Ireland, DocShifter

Learn how you can leverage modern rendering capabilities to automate many additional use cases. Some practical examples:

• Preparing multiple compliant global PDF renditions simultaneously, and fixing technical and formatting issues with Word
• Applying ToCs, cover pages and pagination, and making your text searchable.
• Conversions to non-PDF formats and preparing for longer-term archive platforms.

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AI-powered Advances & Automated Submission Assembly
Jim Nichols, Phlexglobal Ltd.

AI-powered Advances & Automated Submission Assembly
Jim Nichols, Phlexglobal Ltd.

Driven by the LORENZ/PharmaLex partnership, we will preview the advances being made in leveraging submission document content to assist in identifying the placement of those documents into the eCTD structure. PharmaLex has infused its PhlexDMS document management platform with its AI engine - PhlexNeuron - so that documents are analyzed in realtime and tagged with metadata automatically so that the latest version of docuBridge can leverage the information in its assisted compilation functionality. Anticipated time savings of 50-80% can be achieved through this intelligent automation.
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Simplifying the Publishing and Maintenance of Investigational Medicinal Product Dossiers (IMPDs)
Swathi Pandhiti, MMS Holdings Inc.

Simplifying the Publishing and Maintenance of Investigational Medicinal Product Dossiers (IMPDs)
Swathi Pandhiti, MMS Holdings

In this session we will show how docuBridge can help effortlessly overcome the challenges associated with publishing, managing, and maintaining Investigational Medicinal Product Dossiers (IMPDs) especially when dealing with multiple products, formulations, and strengths. We will show a range of docuBridge features that streamline the publishing process and enhance efficiency.
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Health Canada Updates
Irena Pastorekova, Health Canada

Health Canada Updates
Irena Pastorekova, Health Canada

This session provides an update on Health Canada’s electronic submission policy, including regulatory enrolment process (REP) and use of the gateway. With the adoption and expansion of the use of XML files, Health Canada is continuing to move towards its goal of having a ‘Common Submission Intake’ process, where submissions/transactions in electronic format are received via the gateway, automatically validated and imported to docuBridge. In addition, Health Canada provides updates on the Product Monograph in XML format process, guidance and the timelines.
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Stop Emailing Me, Annotate Me Instead…Using Annotation Feature for Submission Review
Ginny Smith, United Therapeutics Corporation

Stop Emailing Me, Annotate Me Instead…Using Annotation Feature for Submission Review
Ginny Smith, United Therapeutics Corporation

This session will demonstrate how the updated annotation feature in docBridge 22.2 can streamline the QC process. Currently, we often have multiple e-mail chains with various folks who need to review a submission, and using e-mails to address comments can be a challenge. With version 22.2, Regulatory Affairs can add comments to the submission itself, where Publishers can easily respond to them.
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Business Benefits, Approaches and Insights Gained from Regulatory Intelligent Automation Implementations
Cary Smithson, PharmaLex

In this presentation, we will share how life sciences regulatory organizations are leveraging intelligent automation (IA) technologies for greater business efficiency, speed to market and regulatory compliance. We will outline use cases they have implemented, and the value realized to date. In addition, we will cover how to get started in IA, defining a business case and calculating ROI.
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Building Grouped Submissions: Tips for Success
Allison Steffen, WAYS Pharmaceutical Services

Building Grouped Submissions: Tips for Success
Allison Steffen, WAYS Pharmaceutical Services

In the US, Grouped Submissions are a unique technical option that allows sponsors to build a single sequence that can distribute documents to several different applications simultaneously. This approach can seem daunting, so in this session, we give experience-based insight for those new to the process, covering scenarios where it is permitted and provides added efficiency, and where it does not.
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Reusing EU Marketing Authorisation Application in the US and Vice Versa
Claudia Bernal-Vallejo, LORENZ Life Sciences Group

Reusing EU Marketing Authorisation Application in the US and Vice Versa
Claudia Bernal-Vallejo, LORENZ Life Sciences Group

Customers who submit in both the EU and US markets can face a situation where they have to plan the initial authorization applications simultaneously. This session offers key learnings for exactly this scenario, covering the differences between EU and US eCTDs, how docuBridge supports compiling them in parallel, and how to save time during the process.
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Functions & Permissions: Differences Between Groups & Roles
Sebastian Hagedorn, LORENZ Life Sciences Group

Functions & Permissions: Differences Between Groups & Roles
Sebastian Hagedorn, LORENZ Life Sciences Group

In this session you will learn about the principles of docuBridge User Management, and its functions and permissions which are managed via Groups and Roles. This will allow you to better understand how you can optimize your Users, utilize Access Control List and Named Permissions and limit unwanted possibilities in your environment.
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Simplifying Submission Handling and Sending: Introducing the Submission Repository
Anna Kispál, LORENZ Life Sciences Group

Simplifying Submission Handling and Sending: Introducing the Submission Repository
Anna Kispál, LORENZ Life Sciences Group

This session explores the benefits of the Submission Repository, a web application developed by LORENZ. Participants will learn how to streamline their submission processing and optimize efficiency, and get a demonstration of the Submission Repository, including scanning, validation, bulk import, and seamless transmission of sequences to regulatory agencies such as the USFDA and Health Canada.
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Keynote
Raoul-A. Lorenz, LORENZ Life Sciences Group

Practical Experiences from US FDA eCTD 4.0 Pilot
Jessica Lemley, LORENZ Life Sciences Group

Practical Experiences from US FDA eCTD 4.0 Pilot
Jessica Lemley, LORENZ Life Sciences Group

Advances in the eCTD 4.0 structure are enabling Health Authorities to become more efficient in reviewing applications. There have been many thoughts and conversations on this topic. In this session, we will discuss real life experiences with the docuBridge eCTD 4.0 POC during the US FDA Pilot and the take-aways that led to changes to the eCTD 4.0 template for compliance and ease of use.
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What's New in docuBridge
Parul Patel & Jessica Lemley, LORENZ Life Sciences Group

What's New in docuBridge
Parul Patel & Jessica Lemley, LORENZ Life Sciences Group

In this table tutorial we'll discuss how to use the exciting new features that have been added to LORENZ docuBridge since 23.1. You will also get a sneak peek at the new features to be introduced in the newest version, docuBridge 23.2.
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Options for Access Restriction
Kristina Roberson, LORENZ Life Sciences Group

Options for Access Restriction
Kristina Roberson, LORENZ Life Sciences Group

LORENZ docuBridge FIVE can be configured for access restriction in several different ways, based on customer requirements. We also offer a baseline approach for CROs to complement the Best Practice Configuration, newly developed based on real customer requirements. In this session, we will look at several approaches to access restriction and present the new baseline configuration for CROs.
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LORENZ Regulatory Content Management (RCM)
Jakob Schlösinger, LORENZ Life Sciences Group

LORENZ Regulatory Content Management (RCM)
Jakob Schlösinger, LORENZ Life Sciences Group

LORENZ is extending its portfolio of off-the-shelf solutions by launching LORENZ Regulatory Content Management (RCM), which can be included with docuBridge FIVE. This enables collaborative creation and management of regulatory along the entire lifecycle. RCM is part of the LORENZ RIM Solution and will be launched in Q3/2023, with additional functionality and benefits being developed over time.
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LORENZ MetaSync – Flexible Metadata Synchronization
Dr. Katharina Schmitz, LORENZ Life Sciences Group

LORENZ MetaSync – Flexible Metadata Synchronization
Dr. Katharina Schmitz, LORENZ Life Sciences Group

Learn how to utilize our Automation capabilities with LORENZ metaSync to integrate your LORENZ RIM Solution with other components of your system environment. LORENZ metaSync is designed to seamlessly synchronize metadata between the LORENZ RIM Solution and 3rd party components, while offering flexible configuration options to define the set of data to be updated. In this table tutorial, we will show you examples of use cases of this solution and present the technical prerequisites that need to be fulfilled to use it to its full potential.
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How LORENZ RIM Supports Registration Tracking & Reporting
Matthias Spiller, LORENZ Life Sciences Group

How LORENZ RIM Supports Registration Tracking & Reporting
Matthias Spiller, LORENZ Life Sciences Group

This table tutorial will demonstrate a best practice use case, highlighting a Regulatory Registrations workflow: from linking your Submission in docuBridge with a Regulatory Activity in drugTrack and using drugTrack to access the Submission and check its content in detail, to using the Reporting feature to view real-time information.
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Regulatory Update Including eCTD 4.0
Akira Yamaguchi, LORENZ Life Sciences Group 

Regulatory Update Including eCTD 4.0
Akira Yamaguchi, LORENZ Life Sciences Group 

This session provides an overview of emerging trends in global Regulatory Operations, focusing on specification updates and important deadlines for compliance.
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