Lorenz Events

Africa and the rapid emergence of eCTD as a regional format
Kent Briggs, VECTOR Life Sciences

Africa and the rapid emergence of eCTD as a regional format
Kent Briggs, VECTOR Life Sciences

South Africa is already an established eCTD market, but with regions like ECOWAS adopting eCTD and discussions of pilots from northern, eastern, and southern locations and even of continental pilots with the emergence of the African Medicines Agency, eCTD is rapidly taking hold across the continent. In this presentation, we will look at West Africa, South Africa, and the trends around the rest of the continent.
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Health Canada Regulatory Update
Tracy Brown, Health Canada

Health Canada Regulatory Update
Tracy Brown, Health Canada

This session provides an update on Health Canada’s electronic submission policy, including the 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 toward its goal of having a ‘Common Submission Intake’ process, where submissions in electronic format are received via the gateway, automatically validated, and imported to docuBridge. In addition, Health Canada will provide updates on the Product Monograph in XML format guidance and the timelines.
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Introducing Regulatory Content Management in LORENZ docuBridge
Adam Burgess, LORENZ Life Sciences Group

Introducing Regulatory Content Management in LORENZ docuBridge
Adam Burgess, LORENZ Life Sciences Group

Adam Burgess will introduce the new Regulatory Content Management (RCM) capability in LORENZ docuBridge. The presentation will provide an overview of the new functionality and show how it can be used in a few scenarios.
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How to efficiently align the strategic and operational aspects of Regulatory Affairs
Filip Cvetanovski, Alkaloid AD Skopje 

How to efficiently align the strategic and operational aspects of Regulatory Affairs
Filip Cvetanovski, Alkaloid AD Skopje 

The subject of this talk is the exploration of strategies for optimizing the synergy between strategic and operation facets within RA. By comprehensively analyzing foundational principles and the judicious utilization of cutting-edge technologies, RA departments can significantly enhance efficiency. This ensures a harmonious alignment between overarching regulatory strategies and the intricate details of day-to-day operation execution. The seamless integration of these crucial dimensions not only streamlines regulatory processes but also fortifies compliance efforts. Such enhancements empower organizations to navigate the dynamic and ever-evolving regulatory landscape with heightened agility, reinforcing their commitment to regulatory excellence, innovation, and overall more sound services to the patients.
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Efficiency gains when working with PDFs in regulatory
Paul Ireland, DocShifter

Efficiency gains when working with PDFs in regulatory
Paul Ireland, DocShifter

For those that are (unfortunately) old enough to remember, PDF was not always the golden child of regulatory submissions. It used to be a truck load of pallets with physical paper. With the introduction of electronic submissions, and harmonization efforts like eCTD, the PDF format benefitted from an increased popularity. However, efficiency gains in creating and preparing PDFs can still be achieved. How? Through automation. This presentation talks about tips and tricks to automate PDF preparation for content in your regulatory submissions.
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Do you want to ensure your authorized product information is correct? Use LORENZ (drugTrack) PI View Edition to verify data accuracy
Patrick Kunkel, LORENZ Life Sciences Group

Do you want to ensure your authorized product information is correct? Use LORENZ (drugTrack) PI View Edition to verify data accuracy
Patrick Kunkel, LORENZ Life Sciences Group

Do you want to avoid incorrect authorized data? In this session, we will outline the latest regional IDMP regulatory updates from EMA with regards to its current migration activities from SIAMED II and XEVMPD to the PMS. In light of these recent developments, LORENZ has created the drugTrack PI View Edition: a solution which allows you to verify your authorized product information registered in the xEVMPD database and helps to avoid PMS migration issues. It also supports you in easily verifying the yearly chargeable unit reports or invoices for PSUR reports. Departments, such as Quality or PV, who are interested in authorized data in contrast to productive regulatory data can get access to the data they need. Additional registration standards, such as SPL or IDMP, will be supported in the future.
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STOP! PREPARE! ACT! eCTD 4.0 and how to be prepared for 2029!
Jessica Lemley, LORENZ Life Sciences Group 

STOP! PREPARE! ACT! eCTD 4.0 and how to be prepared for 2029!
Jessica Lemley, LORENZ Life Sciences Group 

LORENZ docuBridge brings forth a brand-new eCTD 4.0 template structure that will enable industry to comply with health authority deadlines for ICH guidance compliance. The new eCTD 4.0 will help authorities become more efficient in reviewing applications and sequences. This session will discuss the new template and get you ready for the upcoming changes that truly will be easy to use.
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IDMP readiness – How PMS will evolve in 2024 and the crucial role of XEVMPD data in the process
Karl-Heinz Loebel, Pharmalex GmbH

IDMP readiness – How PMS will evolve in 2024 and the crucial role of XEVMPD data in the process
Karl-Heinz Loebel, Pharmalex GmbH

For several years EMA has been moving forward in the implementation of its SPOR database. Especially for the PMS subsystem that will contain all particulars on European pharmaceutical products several enhancements are foreseen for 2024 and beyond. The data already stored in the established XEVMPD data base will play a crucial role for this enhancement and we will look into what Marketing Authorization Holders will have to do to get their product data ready for PMS. We will analyze the potential pitfalls in XEVMPD data and how to overcome these and also how the new LORENZ XEVMPD-viewer tool can support industry with these tasks.
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Keynote
Raoul-A. Lorenz, LORENZ Life Sciences Group

Do you want to ensure your authorized product information is correct? Use LORENZ (drugTrack) PI View Edition to verify data accuracy
Dr. Grace Ng-Krülle, LORENZ Life Sciences Group

Do you want to ensure your authorized product information is correct? Use LORENZ (drugTrack) PI View Edition to verify data accuracy
Dr. Grace Ng-Krülle, LORENZ Life Sciences Group

Do you want to avoid incorrect authorized data? In this session, we will outline the latest regional IDMP regulatory updates from EMA with regards to its current migration activities from SIAMED II and XEVMPD to the PMS. In light of these recent developments, LORENZ has created the drugTrack PI View Edition: a solution which allows you to verify your authorized product information registered in the xEVMPD database and helps to avoid PMS migration issues. It also supports you in easily verifying the yearly chargeable unit reports or invoices for PSUR reports. Departments, such as Quality or PV, who are interested in authorized data in contrast to productive regulatory data can get access to the data they need. Additional registration standards, such as SPL or IDMP, will be supported in the future.
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Health Canada Regulatory Update
Irena Pastorekova, Health Canada

Health Canada Regulatory Update
Irena Pastorekova, Health Canada

This session provides an update on Health Canada’s electronic submission policy, including the 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 toward its goal of having a ‘Common Submission Intake’ process, where submissions in electronic format are received via the gateway, automatically validated, and imported to docuBridge. In addition, Health Canada will provide updates on the Product Monograph in XML format guidance and the timelines.
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What’s new in LORENZ docuBridge 24.1
Madison Porter, LORENZ Life Sciences Group

What’s new in docuBridge 24.1
Madison Porter, LORENZ Life Sciences Group

In this tutorial we'll discuss how to use the exciting new features added to LORENZ docuBridge since version 23.2, and you will also get a sneak peak of the new features to be introduced in the newest version of docuBridge 24.1.
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Regulatory cloud modernization - enabling research and review with trusted regulatory spaces
Omar Serang, DNAnexus, Inc.

Regulatory cloud modernization - enabling research andreview with trusted regulatory spaces
Omar Serang, DNAnexus, Inc.

The DNAnexus multi-omics and RWD collaboration cloud enables transformational advances in regulatory science and review. DNAnexus has evolved from a Next Generation Sequencing bioinformatics platform to become a global collaborative cloud hub for regulatory research and effective sponsor-reviewer interactions. The foundations of this cloud enablement have been the DNAnexus FedRAMP Authorization, ISO 27001 certification, and Data Processor commitments under GDPR to manage protected healthcare data and personally identifiable information. These authorizations enable cloud regulatory research and review use cases that have previously been unachievable, and this presentation will highlight the projects and enabling capabilities that have been realized on DNAnexus to achieve this.
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Update of electronic submission in China and demo of solution with docuBridge
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

Update of electronic submission in China and demo of solution with docuBridge
Jeremy Yi, Beijing ERIS Information Technology Co., Ltd.

From December 29, 2021, China’s Center for Drug Evaluation (CDE) started receiving eCTD submissions from specific NDA applications, and from March 1, 2024, all the submissions must be submitted in electronic format with new electronic submission specification and validation criteria, and an electronic stamp is required as well. Applicants have to consider different tactics for different types of applications which require better understanding of the policy and support of strong electronic submission solutions. This presentation will explain the details of the regulatory requirements and introduce the useful solution with docuBridge.
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