Lorenz Events

Electronic Submissions - Moving Towards Global Aspects
Dr. Marjan Dzeparoski, Bionika Pharmaceuticals

eSubmissions are gradually becoming mandatory around...
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Electronic Submissions - Moving Towards Global Aspects
Dr. Marjan Dzeparoski, Bionika Pharmaceuticals

eSubmissions are gradually becoming mandatory around the world, and countries in the Balkan region are following this global trend. This presentation will give a detailed overview of current and planned submission formats in Serbia, Montenegro and Albania as well as Bosnia and Kosovo.
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A Vision for the Future: Full Exception-based Quality Processes
Klavs Esbjerg, Epista Life Sciences

A paradigm shift is needed to bring Life Science into the...
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A Vision for the Future: Full Exception-based Quality Processes
Klavs Esbjerg, Epista Life Sciences

A paradigm shift is needed to bring Life Science into the 21st century. The FDA is on board with the move from CSV to CSA. And we know that one of the cornerstones of this shift is test automation, designed to help companies handle continuous patches, upgrades, and more. Join us to learn how you can already reach the full potential of digitalization for your time-consuming, quality-associated tasks today.
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AI in Pharma Business
Dr. Andreas Franken, Bundesverband der Arzneimittel-Hersteller e.V BAH

Big Data or Real World Data are keywords in...
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AI in Pharma Business
Dr. Andreas Franken, Bundesverband der Arzneimittel-Hersteller e.V. BAH

Big Data or Real World Data are keywords in many discussions and projects on a European level. Even COVID-19 has shown the value of collecting health information in registers, databases and other repositories. Together with the EU Commission, regulators are working on a framework to increase the acceptance of results created by studies conducted with such data. AI can help to manage these types of projects.
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The Path to a High Performance RIM Capability and Operation
Steve Gens, Gens Asocciates

This session will focus on the traits...
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The Path to a High Performance RIM Capability and Operation
Steve Gens, Gens Asocciates

This session will focus on the traits that top performing companies exhibit from the Gens & Associates World Class RIM benchmarks. It will review specific process and organizational practices that boast data quality sustainability and operational efficiency along with a glimpse to how top performing regulatory functions are investing in their RIM program and operations.
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Update on Chinese eCTD
Sophia Huang, Bayer Healthcare Company Limited

This session is divided into two main portions. The first is an overview...
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Update on Chinese eCTD
Sophia Huang, Bayer Healthcare Company Limited

This session is divided into two main portions. The first is an overview of Chinese eCTD developments including the major milestones. The other part of the session will focus on my personal interpretation of draft Chinese eCTD guidelines recently released by CDE, including the Chinese eCTD specification, validation and business guide.
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Regulatory MA Pathways in the EU
Dr. Michael Jandke, Miltenyi Biomedicine GmbH

This Session will offer a high level overview...
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Regulatory MA Pathways in the EU
Dr. Michael Jandke, Miltenyi Biomedicine GmbH

This session will offer a high level overview of the mostly common but partially differentiated registration processes within the EU. In addition, it will cover the timelines and procedural steps of mutual recognition (MRP), de-centralised (DCP) and centralised procedures (CP). 
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IDMP Awareness
Magdalena Kozlowska-Krupa, Accenture

IDMP is one of the greatest challenges facing...
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IDMP Awareness
Magdalena Kozlowska-Krupa, Accenture

IDMP is one of the greatest challenges facing pharma today, but what should companies consider before deciding the best approach? Such an enterprise involving multiple stakeholders and data sources sounds complex, but also represents a real opportunity to use innovation and develop AI tools to create IT solutions and build one system connecting regulatory, clinical, manufacturing, PV and supply.
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Digitalization and Intelligence in Regulatory Affairs Systems
Don Lebitsa, Adcock Ingram Limited

The rapid changes in the regulatory space globally...
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Digitalization and Intelligence in Regulatory Affairs Systems
Don Lebitsa, Adcock Ingram Limited

The rapid changes in the regulatory space globally including the use of technology give regulatory affairs teams an opportunity to digitalize, harmonize and integrate regulatory information and systems within an organisation.
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A Brief Journey to the Global eCTD World
Karl-Heinz-Loebel, PharmaLex GmbH

As the eCTD is captures larger and larger share of...
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A Brief Journey to the Global eCTD World
Karl-Heinz-Loebel, PharmaLex GmbH

As the eCTD captures a larger and larger share of the Regulatory world, industry's own struggle to keep up with the varied particularities, interpretations and requirements of the different eCTD regions, is growing. Despite the high level of harmonisation achieved by the ICH standard, an eCTD is not the same everywhere. The modalities of its use are turning out to be rather diverse and constantly changing. This presentation will take you on a tour of the world of eCTDs and point out the main features, key differences, and very latest developments in the different regions from the point of view of the global eCTD publisher. Our journey will start in Europe (UK, EEA, CH), continue to the Middle East (GCC and Jordan), cover mainland Asia (EAEU, CN), include a short visit to Australia, and end in North America (US, CA). For each of the regions, it will describe the terms of eCTD usage, submission pathways, submission portals, validation rules, oddities, trendsetting innovations, potential pitfalls and hurdles, and how to avoid them. We will also have a look at how the different requirements impact planning and preparation for global eCTD submissions. Even if you are not currently involved in eCTD preparations for all of these parts of the world, this voyage will definitely increase your understanding of the needs of your local affiliates or partners, and how to best integrate them into a global eSubmission strategy..
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Building a Next Gen Regulatory Intelligence using NLP
Susant Mallick, Amazon Web Services

Regulatory submissions are becoming more and more critical...
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Building a Next Gen Regulatory Intelligence using NLP
Susant Mallick, Amazon Web Services

Regulatory submissions are becoming more and more critical due to the pandemic situation. This session explores how can we use natural language processing (NLP) and AI/machine learning to build a next-generation regulatory intelligence solution in order to fast track regulatory submissions, build an intelligent submission strategy, and answer Regulatory Authority queries in hours rather than days or than weeks.
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Implementation Guides for eCTD v4.0 - The New Draft from Swissmedic
Dr. med. Klaus Menges, Senior Regulatory Affairs Expert

The implementation of eCTD v4.0 requires region...
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Implementation Guides for eCTD v4.0 - The New Draft from Swissmedic
Dr. med. Klaus Menges, Senior Regulatory Affairs Expert

The implementation of eCTD v4.0 requires region-specific structure elements and controlled vocabularies or specific validation rules. This presentation will compare the IGs from the USFDA, HC, the EU and of the SMC to highlight specific solutions, differences and challenges.  The new Swiss draft IG provides the chance to evaluate the commonalities and differences across regions.
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Health Canada Updates
Dr. Joseph Mikhael, Health Canada

This session will give an update on Health Canada’s eReview initiatives,...
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Health Canada Updates
Dr. Joseph Mikhael, Health Canada

This session will give an update on Health Canada’s eReview initiatives, including its Regulatory Enrolment Process (REP) and Automation projects. With the adoption of REP, eReview at Health Canada is continuing to move towards its goal of having a ‘Common Submission Intake’ process, where structured, electronic submissions are accepted via the Gateway, and automatically validated and imported into docuBridge.
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The Use of Structured Data in a Dossier
Remco Munnik, Iperion Life Sciences

With the developments of IDMP, ePI...
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With the developments of IDMP, ePI, PQ/CMC, more and more regulators are looking to receive and process structured data within the eCTD dossier. Industry has opportunities to gather information in a pre-structured format and share information internally. In this presentation, we will outline the different initiatives and provide an update on the current status of IDMP implementation in Europe.
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