Lorenz Events

Agenda May 17, 2022

Agenda May 18, 2022

Validation Errors, Warnings and Technical Issues - How to Save Time When Contacting LORENZ Support
Freddie Day-Robinson & Sebastian Hagedorn, LORENZ Life Sciences Group

This presentation will provide guidance on ...
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Validation Errors, Warnings and Technical Issues - How to Save Time When Contacting LORENZ Support?
Freddie Day-Robinson & Sebastian Hagerdorn, LORENZ Life Sciences Group

This presentation will provide guidance on how to receive the quickest response to your request for assistance. To assist you in a timely manner, there are specific pieces of information we require. This session covers exactly what information needs to be provided, and will also discuss how to find and attach documents or packages to the support ticket.
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Best Practices Sending Submissions to the US FDA
Adam Burgess, LORENZ Life Sciences Group

He will share tips for submitting published submissions ...
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Best practices sending submissions to the FDA
Adam Burgess, LORENZ Life Sciences Group

Adam Burgess, Regulatory Solutions Consultant, LORENZ Life Sciences Group will share tips for submitting published submissions through the FDA Electronic Submissions Gateway. He will cover switching to the now-mandatory DTD version 3.3, best-practices for submission-transfer, and best-practices around receipt storage.
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Cloud vs. On Premise: Key Differences, Benefits, and Risks
Wladimir Getze, LORENZ Life Sciences Group

In the session, he will explain the benefits of cloud ...
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Cloud vs. On Premise: Key Differences, Benefits, and Risks
Wladimir Getze, LORENZ Life Sciences Group

In the session, he will explain the benefits of cloud services and how the solution is designed regarding security and compliance, validation and user experience. In addition, the pros and cons of the available deployment scenarios (cloud vs on-premises) will be explained, along with the factors to consider in choosing between the two.
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Less Clicking, More Efficiency – Creating and Using Custom Toolbars
Kelly Crossett, Whitsell Innovations, Inc.

The software programs we use on a daily basis have amazing capabilities. ...
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Less Clicking, More Efficiency – Creating and Using Custom Toolbars
Kelly Crossett, Whitsell Innovations, Inc.

The software programs we use on a daily basis have amazing capabilities. They also have a seemingly endless options that we can use to create, format, and edit our documents. However, finding all of those options quickly and easily can be a challenge. The solution I have found in both Microsoft Word and Adobe Acrobat is creating and using custom toolbars and keyboard shortcuts. Custom toolbars can eliminate constant switching between ribbons to find the correct set of buttons and searching long lists of menu items for a specific task. This presentation will demonstrate how to customize toolbars in Word and in Acrobat. It will also provide directions for creating your own keyboard shortcuts in Word and innovative ways to use them. The seconds and minutes that are saved can add up over time and help you increase your overall efficiency.
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EAEU eCTD Experience
Andrey Glukhov, Nizhpharm JSC (STADA Group)

Andrey Glukhov will be sharing his experience on the EAEU ...
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EAEU eCTD Experience
Andrey Glukhov,
Nizhpharm JSC (STADA Group)

Andrey Glukhov, Manager of Regulatory Operations, Nizhpharm JSC (STADA Group) will be sharing his experience on the EAEU eCTD and data submissions. In this session he will cover docuBridge implementation, a summary of the EAEU IT landscape, EAEU master data, dossier submission and a response to letter of deficiency, data submission and other points regarding this topic. He will also help participants to understand how EAEU IT regulatory environment works and how to start working with it.
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Managing Global Regulatory Information: Industry Status and Next Steps
Steve Gens, Gens & Associates Inc.

Steve Gens will be presenting the latest 2022 World Class RIM benchmark data ...
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Managing Global Regulatory Information: Industry Status and Next Steps Steve Gens, Gens & Associates Inc.

Steve Gens will be presenting the latest 2022 World Class RIM benchmark data “hot off the press” with a focus on how industry has progressed in the past 4 years (trending), but more importantly, where is industry investing in the next 2 – 3 years. Steve will segment the study data between the large / mid-tier companies (complexity) and smaller organizations (grow and scale) as many investment differences exist here. Research topics include investment in the 15 RIM capabilities, new organizational roles, end-to-end process enhancement priorities, advanced technology investment priorities and value, outsourcing status, and the projection of the pace / strategy for upcoming structured data submissions (IDMP/SPOR,PQ/CMC etc.).
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The Benefits of Assisted Compilation
Kristin Holmes, iNova Pharmaceuticals (Pty) Ltd

Due to the backlog clearance project initiated ...
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The Benefits of Assisted Compilation
Kristin Holmes, iNova Pharmaceuticals (Pty) Ltd

Due to the backlog clearance project initiated by the South African Health Products Regulatory Authority in South Africa (SAHPRA) in 2019, industry was forced to move away from paper-based submissions to an electronic format, either eSubmission (manual eCTD structure) or eCTD. A standard configuration of docuBridge is installed in South Africa in line with the relevant local eCTD requirements. Assisted compilation was introduced in the 19.2 version update. Manual compilation requires that individual documents are dragged into the specific node content. Assisted compilation allows for multiple documents to be dragged into the assisted compilation pane, appearing on the bottom of the outline pane, and enables auto compiling of multiple documents simultaneously in the relevant node, without any set template structure. Multiple documents from different modules can now be dragged into the compilation pane together, which will provide a summary of the number of documents, and also allows for sorting the view by section or description. docuBridge will then automatically compile the documents into the correct sections of the eCTD with the click of a button. Assisted compilation requires a consistent approach to naming convention (and descriptions applied) in line with relevant guidelines or requirements. Saving time to auto compile the documents rather than manually compiling each document node by node, takes away the burden of having to check each node, while allowing more time to be allocated to the quality control of the documents themselves, rather than an eCTD structure.
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docuBridge userGroup Update
Philip Hall, Senior Consultant

The docuBridge userGroup was created ...
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docuBridge userGroup Update
The docuBridge userGroup was created last September to enable docuBridge users to share technical issues, and get peer advice on regulatory issues. The presentation will describe why we started the group, how successful it has been, and provide details on how we hope to further expand and develop it.
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Achieving PDF Compliance Earlier Via Automated Checking & Fixing of Word & PDF Content
Paul Ireland, DocShifter

This presentation outlines how to identify issues with Word ...
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Achieving PDF Compliance Earlier Via Automated Checking & Fixing of Word & PDF Content
Paul Ireland, DocShifter

This presentation outlines how to identify issues with Word and PDF files earlier in your content preparation processes, and also covers how to reduce the risks associated with discovering content-related problems later during the publishing stages. It will explain that it is possible to look for and fix Word content issues fully automatically, prior to conversion into PDF format. Then it will move on to performing PDF compliance checks without human intervention, resolving any issues systematically and reporting any remaining items of concern. The session will outline what types of checks can be performed and the potential time savings and overall benefits from this type of automation.
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Data Management With LORENZ
Dr. Jens Heller, LORENZ Life Sciences Group

The LORENZ suite can help you track your own data ...
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Data Management With LORENZDr. Jens Heller,
LORENZ Life Sciences Group

In this session you will learn how the LORENZ suite can help you track your own data and comply with upcoming data standards such as IDMP in EU but also world wide. Data is a strategic asset and that is why you have to manage it as effectively and efficiently as possible. This session will provide you with an overview of the benefits of drugTrack, our product information and tracking tool. You will learn about the modular structure of our product information and tracking tool, which allows you to find the best fit for you.
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Be (EU IDMP) Compliant with LORENZ
Patrick Kunkel, LORENZ Life Sciences Group

The IDMP standard has been in development ...
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Be (EU IDMP) compliant with LORENZ
Patrick Kunkel, LORENZ Life Sciences Group

The IDMP standard has been in development for over 15 years and is now quickly becoming a reality. This session will give you an update on the latest developments on IDMP and DADI in Europe as well as IDMP globally and how you can achieve compliance using drugTrack, our product information and lifecycle management solution. You will also learn how you can comply with any other future data standard, and how to manage your own data as effectively and efficiently as possible.
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Dynamic Submission Management
Lorelle Leonienco and Charles Mathis, LORENZ Life Sciences Group

There are many transformative industry changes ...
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Dynamic Submission Management
Lorelle Leonienco and Charles Mathis, LORENZ Life Sciences Group

There are many transformative industry changes in the life sciences space being discussed today, and we at LORENZ believe we are entering a major new phase of evolution with submission management. We call this “dynamic submission management (DSM)”. In this session, we will explore key trends and concepts from our 2022 white paper and discuss how LORENZ is shaping and supporting this transition.
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LORENZ Keynote
Raoul-A. Lorenz, LORENZ Life Sciences Group

Health Canada Updates
Irena Pastorekova & Tracy Brown, Health Canada

This session provides an update on Health Canada’s electronic submission policy ...
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Health Canada Updates
Irena Pastorekova & 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.
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What's New in LORENZ drugTrack
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

This session will provide features and UI updates on our product ...
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What's New in LORENZ drugTrack
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

This session will provide features and UI updates on our product information and tracking tool. Dr. Grace Ng-Krülle, Senior Regulatory Product Consultant will cover software usability highlights, as well as the latest regulatory updates within the EU Region (specifically CTR on XEVMPD product information). She will also help participants understand the importance of data quality for Article 57(2), and how structured data from the XEVMPD will continue to be important for the EU IDMP implementation (PMS and the DADI project.)
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What's New in LORENZ docuBridge
Kristina Roberson, LORENZ Life Sciences Group

In this tutorial we'll discuss how to use the exciting ...
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What's New in LORENZ docuBridge
Kristina Roberson, LORENZ Life Sciences Group

In this tutorial we'll discuss how to use the exciting new features added to LORENZ docuBridge since 21.2 and give you a sneak peak of the new features to be introduced in the newest version of docuBridge 22.1.
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Best of Both Worlds: The Co-existence of Structured and Unstructured Regulatory Information
Timm Pauli, PharmaLex GmbH

The last years have been a tremendous success but also a challenge ...
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Best of both worlds: the co-existence of structured and unstructured Regulatory information
Timm Pauli, PharmaLex GmbH

The last years have been a tremendous success but also a challenge when applying and utilizing new digital technologies and data standards to Regulatory Affairs. Interoperability with other key functions was needed to implement new data standards and software systems. We will explore how a defined cross-functional informatics entity can foster Regulatory Operational Excellence and why eCTD submissions will continue to play an important role.
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A Year of Ad Promo Electronic Submissions
Ginny Smith & Rachelle Higgs, United Therapeutics Corporation

It has been about a year since FDA required ...
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A Year of Ad Promo Electronic Submissions
Ginny Smith & Rachelle Higgs, United Therapeutics Corporation

It has been about a year since FDA required ad promo submissions be submitted in eCTD. During this session, United Therapeutics will discuss the transition, the process adopted, and issues faced along the way. The focus will be primarily on 2253 submissions. We will also have time for others to discuss their successes and challenges.

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China eCTD Development, Requirements and Practices
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

On September 30, 2021, China published its eCTD implementation ...
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China eCTD Development, Requirements and Practices
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

On September 30, 2021, China published its eCTD implementation announcement, indicating that starting on December 29, 2021, initial applications for marketing authorizations for Type 1 and Type 5.1 chemical drugs, as well as for Type 1 therapeutical biologics and Type 1 preventative biologics, could be submitted in the eCTD format. It is expected that the scope of eCTD submissions will be extended in the near future. The China Center for Drug Evaluation has been developing the eCTD for almost 6 years. The launch of the eCTD format in China brings great challenges and opportunities for local and international companies. This presentation will give an overview of the development of the Chinese eCTD, its major technical aspects and practices for eCTD submissions in China.
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eCTD v4.0 – Updates and Conceptual Considerations
Akira Yamaguchi, LORENZ Life Sciences Group

The presentation shall provide updates, conceptual overviews ...
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eCTD v4.0 – Updates and conceptual considerations
Akira Yamaguchi, LORENZ Life Sciences Group

After years of specification development, some regulatory agencies are considering the eCTD v4.0 implementation. The presentation shall provide updates, conceptual overviews with implication to the industry.

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