Lorenz Events

ICH Initiatives: What are they and why they matter.
Brooke Casselberry, Vice President, Advisory and Delivery, Epista Life Science

ICH Initiatives: What are they and why they matter.
Brooke Casselberry, Vice President, Advisory and Delivery, Epista Life Science

This presentation will cover the key ICH initiatives that have a direct impact on the data elements across the eCTD, how they relate, and why they are important. The ICH initiatives covered are M4Q(r2) = M2/M3; Q12 = CMC Post approval changes, Quality Risk Based Development and Established Conditions; M11 = M2/M5 Clinical; and, of course, Brooke will touch on IDMP, because it has influence on all of these.
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Data to Dashboard: Challenges and Opportunities to set up KPI Analytics
Susan Clarke, Merz Therapeutics

Data to Dashboard: Challenges and Opportunities to set up KPI Analytics
Susan Clarke, Merz Therapeutics

KPI reports are becoming more important in the industry than ever before: quality control, planning, compliance checks, data analysis, performance… the needs are many, the solutions are few. At Merz Therapeutics, we have decided to step away from tiresome manual reporting and approach a more efficient process using the drugTrack dashboards. Let me show you how!
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China eSubmission and eCTD Submission: Policy Updates with far-reaching Implications
Sophia Huang, General Manager, Beijing BrilliantMed Pharma Tech Co., Ltd.

China eSubmission and eCTD Submission: Policy Updates with far-reaching Implications
Sophia Huang, General Manager, Beijing BrilliantMed Pharma Tech Co., Ltd.

On January 23, 2025, NMPA announced to expand the eCTD implementation scope. This presentation will offer insights into the implementation timeline, the major characteristics of Chinese eSubmissions and eCTD dossiers and the broader industry impact. These insights will help stakeholders prepare for a smoother transition to the new regulatory framework.
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Content Preparation, Conversion & Enrichment - Benefits of using DocShifter with docuBridge
Paul Ireland, DocShifter

Content Preparation, Conversion & Enrichment - Benefits of using DocShifter with docuBridge
Paul Ireland, DocShifter

As officially announced during last year's Converge event, LORENZ has officially selected DocShifter as their document conversion engine to power LORENZ docuBridge. Join us for this session as we explore how DocShifter can enhance your submission content preparation and PDF conversion experience in LORENZ docuBridge. Discover how DocShifter enables faster processing, improved accuracy, and smarter automation - with and without AI.
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eCTD 4.0 in Action - #justanotherformat
Anna Kispál & Maximilian Muth, LORENZ Life Sciences Group

eCTD 4.0 in Action - #justanotherformat
Anna Kispál & Maximilian Muth, LORENZ Life Sciences Group

Are you already daunted by eCTD v4.0? No worries, we’ve got you covered. In this session, we will discover the key differences between eCTD v3.2 and the next major version, 4.0. Through an interactive demonstration, participants will be introduced to the new characteristics—such as document reuse, keyword handling, and forward compatibility. By showcasing the practical applications of eCTD 4.0, we want to empower users to embrace this upgrade with confidence. Join us in discovering how our software makes navigating these changes not just manageable, but truly effortless. With us, eCTD 4.0 is #justanotherformat.
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AI-Powered Regulatory Content Validation: Pilot Results
Anna Kispál, LORENZ Life Sciences Group & Rainer Schwarz, KlearDoc/LORENZ Life Sciences Group

AI-Powered Regulatory Content Validation: Pilot Results
Anna Kispál, LORENZ Life Sciences Group & Rainer Schwarz, KlearDoc/LORENZ Life Sciences Group

LORENZ is bringing an AI-powered regulatory content validator to market, designed to enhance accuracy and efficiency in eCTD submissions. Pilot tests with customers on Type 1A variations, such as manufacturing updates, delivered highly promising results. This presentation will introduce the new LORENZ software tool, showcase case study findings, and feature a live demo.
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LORENZ Keynote
Patrick Kunkel & Raoul A. Lorenz, LORENZ Life Sciences Group

Navigating EMA's IRIS Dataverse
Karl-Heinz Loebel, PharmaLex GmbH

Navigating EMA's IRIS Dataverse
Karl-Heinz Loebel, PharmaLex GmbH

Over the last years the European Medicines Agency (EMA) has built up several inter-connected databases, process management tools, and user interfaces to handle the agency’s regulatory data. These include the SPOR master data management system, IRIS and PLM Portals, and the ESMP platform. Industry needs to interact with all these systems in various ways to ensure compliance with regulations and to perform daily regulatory and pharmacovigilance tasks. To do so efficiently, industry users need to understand the inter-dependence of the data stored in these systems, their data maintenance obligations, and the different access levels required for accessing and using the data. Companies may also have to reconsider their own internal data management approach. The preparation of electronic Variation Application Forms via the PLM Portal and Shortage Reporting to the ESMP platform will be used to illustrate these challenges.
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What's new in LORENZ RIM 25.1
Donna Manley & Mathias Spiller, LORENZ Life Sciences Group

What's new in LORENZ RIM 25.1
Donna Manley & Mathias Spiller, LORENZ Life Sciences Group

This session will preview the main new features of LORENZ RIM Solution 25.1.
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Fostering Dynamic Submission Management (DSM) - Innovation through Trusted Regulatory Spaces (TRS)
Omar Serang, DNAnexus, Inc. & Akira Yamaguchi, LORENZ Life Sciences Group

Fostering Dynamic Submission Management (DSM) - Innovation through Trusted Regulatory Spaces (TRS)
Omar Serang, DNAnexus, Inc.& Akira Yamaguchi, LORENZ Life Sciences Group

The complexity of managing dynamic regulatory submissions is driving the need for cloud-based digitalization, harmonization, and normalization of regulatory information. This session explores how leveraging global standards and Standards Development Organizations (SDOs) can enhance efficiency, interoperability, and AI-driven analysis of regulatory data. Key topics include the adoption of structured data and eCTD 4.0, AI integration to automate compliance workflows, and addressing jurisdictional challenges. By fostering trusted regulatory spaces, life sciences organizations can collaborate effectively while ensuring security and privacy. Attendees will gain actionable strategies to leverage regulatory cloud platforms for streamlined submissions and global compliance.
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Advancing Pharmaceutical Regulatory in Africa: Current Progress and Collaboration
Dr. Madelein Terblanche, VECTOR Life Sciences

Advancing Pharmaceutical Regulatory in Africa: Current Progress and Collaboration
Dr. Madelein Terblanche, VECTOR Life Sciences

Pharmaceutical regulatory activities in Africa are advancing through regional harmonization and digital transformation. The African Medicines Agency (AMA) fostered collaboration among national regulators, while initiatives like ECOWAS accelerated harmonization. Digital tools, including eCTD and integrated systems, streamlined submissions and approvals, supported by capacity-building programs to enhance expertise. Partnerships with organizations like AUDA-NEPAD promoted knowledge sharing, boosting regulatory efficiency and access to quality medicines. These efforts aligned with AMA’s vision to ensure safe, effective, and affordable medicinal products for all Africans, reinforcing the continent’s regulatory landscape and improving public health outcomes.
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Leveraging Innovative Trends in Regulatory Operations
Kosta Uzelac, Celegence

Leveraging Innovative Trends in Regulatory Operations
Kosta Uzelac, Celegence

Staying ahead of submission trends is crucial for pharmaceutical organizations. This session explores four key development areas that are shaping the current landscape: eCTD 4.0, FDA KASA, ICH M4Q revision, and use of AI and automation. Focusing on the "why" rather than the technical details, we will examine their business impact, including streamlining processes, enhancing reusability, and improving data and document management. Discover how these trends are redefining regulatory operations by driving efficiency, compliance, and strategic advantage in the pharmaceutical industry. Join and you will gain actionable insights to prepare for the future of regulatory submissions.
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