Lorenz Events

Lundbeck Cloud Applications and Release Planning
Ida Bastian Brügger, H. Lundbeck A/S 

Lundbeck Cloud Applications and Release Planning
Ida Bastian Brügger, H. Lundbeck A/S 

Ida Bastian Brügger will present the current Lorenz landscape implemented at Lundbeck with focus on release planning. Building an internal reusable release plan to ensure anchoring of responsibilities, the correct order of tasks and to make sure the right people are involved at the right time without having a fully agile environment in place.
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Health Canada XML Updates
Tracy Brown, Health Canada

Health Canada XML Updates
Tracy Brown, Health Canada

This presentation will provide an update on Health Canada’s transition to the XML PM and highlight key benefits. A roadmap will review what has been done to date and what’s being planned for the future. This update will cover some recent changes, high level processes and common validation errors.
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Optimizing the Regulatory Submissions Process through the use of Robotic Process Automation
Jennifer Dames, AbbVie Inc.

Optimizing the Regulatory Submissions Process through the use of Robotic Process Automation
Jennifer Dames, AbbVie

Hyperlinking submission documents is a very manual task, that happens at a very critical part of the submission timeline. This case study will highlight how we are transforming the manual work performed during the regulatory submission build process, such as hyperlinking, using robotic process automation. We will provide an overview of the automation, the benefits/value expected, along with some of the challenges that have been encountered throughout the process.
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eSubmissions in Non-EU Countries
Marjan Dzeparoski, Bionika Pharmaceuticals

eSubmissions in Non-EU Countries
Marjan Dzeparoski, Bionika Pharmaceuticals

This presentation will give a detailed overview of current and planned submission formats in Serbia, Montenegro, Albania, Bosnia, Kosovo and Macedonia, as well as in United Arab Emirates as these markets move towards global electronic submissions/eCTD. It will also cover the customized software that Regional National Agencies have developed for electronic submissions, as well as how documents in NeeS and eCTD format can be used for eSubmissions. Get an in-depth look at regulation compliance from the emerging markets and steps to keep up to date on global products within these country-specific environments.
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Assisted Compilation
Kristin Holmes, iNova Pharmaceuticals (Pty) Ltd. 

Assisted Compilation
Kristin Holmes, iNova Pharmaceuticals (Pty) Ltd. 

This session will take a close look the assisted compilation function based on a standard configuration of docubridge as installed in South Africa, in line with the relevant local eCTD requirements. Assisted compilation was introduced in the 19.2 version update. It requires a consistent approach to both the naming conventions and the descriptions applied, in line with relevant guidelines or requirements. Saving time by auto-compiling the documents rather than manually compiling each document by node takes away the burden of having to check each node individually and instead allows for more time for quality control in the actual documents rather than in the eCTD structure.
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What's New in LORENZ docuBridge
Anna Kispál, LORENZ Life Sciences Group 

Discuss how to use the exciting new features...
Anna Kispál, LORENZ Life Sciences Group 

In this tutorial we'll discuss how to use the exciting new features added to LORENZ docuBridge since version 22.2, and also give you a sneak peak of the new features to be introduced in the newest version of docuBridge, 23.1.
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Keynote
Patrick Kunkel, LORENZ Life Sciences Group

Keynote
Patrick Kunkel, LORENZ Life Sciences Group

Keynote
Raoul-A. Lorenz, LORENZ Life Sciences Group

Keynote
Raoul-A. Lorenz, LORENZ Life Sciences Group

eCTD 4.0 FDA Pilot Experience
Teresa Martins, Bayer U.S., LLC

eCTD 4.0 FDA Pilot Experience
Teresa Martins, Bayer U.S., LLC

ICH M8 has posted their eCTD v4.0 Implementation Package v1.5 , and the US FDA has published their eCTD v4.0 Conformance Guide. In addition, the FDA is currently executing and coordinating an eCTD v4.0 technical pilot with industry. This session will provide a first-hand perspective from a pharma company that is actively participating in the pilot and engaging with the US FDA and other industry participants. Attendees can expect to hear updates on the status of the pilot, gain insights on an industry participants’ experience and hear feedback on some of the challenges and benefits of the use of eCTD 4.0. Attend this session if interested in learning more.
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EMA Regulatory Update for EU-IDMP and PMS
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

EMA Regulatory Update for EU-IDMP and PMS
Dr. Grace Ng-Kruelle, LORENZ Life Sciences Group

In this session, Grace will highlight how structured product data submission plays a key role in EMA’s data-centric TOM for pharmacovigilance and regulatory processes, the challenges of data quality, and then conclude with the LORENZ framework on how to best to help the industry (MAHs and Sponsors) during the transition period of the Article 57 databases from XEVMPD to PMS. The current iteration of the PMS will use ISO IDMP compatible data submission format (HL7 FHIR) that covers a subset of the authorised medicinal product part of the ISO IDMP standards. This means the XEVMPD will continue to exist in order to support data submission for unauthorised medicinal products.
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eCTD 4.0 Implementation in Europe – What does it mean for Industry?
Karl-Heinz Loebel, Pharmalex GmbH

eCTD 4.0 Implementation in Europe – What does it mean for Industry?
Karl-Heinz Loebel, Pharmalex GmbH

This presentation will explain the immediate and long-term consequences of eCTD 4.0 implementation in Europe and how industry needs to gear up for it. The European Medicines Agency has disclosed a timeline for eCTD 4.0, targeting its optional use in Centralised Procedure Applications in 2024 and in MRP/DCP submissions the following year. eCTD 4.0 is meant to enable better integration with cloud-based review approaches and cope with more structured information, but not all aspects will feature from the start. So what will eCTD 4.0 actually mean for pharmaceutical companies in practice, and how will it affect compilation processes? This session will provide answers to these questions.
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What’s New in LORENZ drugTrack
Matthias Spiller, LORENZ Lifes Sciences Group

Major changes and improvements ...
Matthias Spiller, LORENZ Lifes Sciences Group

In this presentation, we will present the major changes and improvements in version 23.1 of drugTrack, the data tracking tool in our RIM solution.
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Update and Practice of Electronic Submission in China
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

Update and Practice of Electronic Submission in China
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

This presentation will give an update on eCTD and NeeS development in China, introducing major technical & regulatory requirements, as well as best practices for China submissions. Since December 29 of 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 have been accepted in the eCTD format. So far, around 20 eCTD applications have been submitted to China CDE, and more are expected in 2023. In the meantime, starting on January 1 of 2023, applications of all types of submissions are required to be in an electronic format similar to NeeS.
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