Lorenz Events

Continuing to Adapt: The Continued Evolution of Publisher into Supporting Other Areas and Beyond
Jillian Carinci, Biogen Corporation

Biogen's Submission Sciences team has been focused on increasing ...
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Continuing to Adapt: The Continued Evolution of Publisher into Supporting Other Areas and Beyond
Jillian Carinci, Biogen Corporation

Biogen’s Submission Sciences team has been focused on increasing visibility and opportunities for Regulatory Operations to impact the company priorities. Regulatory Operations personal are continuing to develop an increasing skillset that goes beyond publishing expertise. This case study will follow Biogen’s journey over the past year. Broad-ranging topics will be discussed, from a group re-alignment which maximized synergies to harmonizing skills and processes for a global team. This case study will share Biogen’s current evolution along this journey to empower and develop team members, remove obstacles, and show the benefit to Biogen’s Global Safety and Regulatory Sciences Organisation.
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Word Emergency Kit - Five Things to Check When Your Document Breaks Down
Kelly Crossett, Whitsell Innovations, Inc.

In the ideal world, all documents would arrive as perfect PDFs or ...
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Word Emergency Kit - Five Things to Check When Your Document Breaks Down
Kelly Crossett, Whitsell Innovations, Inc.

In the ideal world, all documents would arrive as perfect PDFs or, at the very least, expertly formatted Word files. However, occasionally we must deal with imperfect documents. When this happens, we need an emergency kit – a set of tools and knowledge that allows us to quickly and efficiently identify and fix the problem. This ensures that any imperfect Word document can be quickly repaired and prepared for the next step in the publishing process. During this session, we will explore five areas that often cause chaos in Word documents and learn the most efficient places to look for solutions.
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Utilizing LORENZ docuBridge and iSubmit for Document/Report Level Publishing
Michelle Farmer, LORENZ Life Sciences Group

Many document types included in a regulatory...
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Utilizing LORENZ docuBridge and iSubmit for Document/Report Level Publishing
Michelle Farmer, LORENZ Life Sciences Group

Many document types included in a regulatory submission are authored as granular documents. At a minimum, these granular documents are concatenated, and as you know concatenation is only the first step towards creating a submission-ready document or report. Perhaps you need to insert a title page, create interdocument hyperlinks, apply overall headers/footers, or create a table of contents. This session is a high-level overview of using LORENZ docuBridge functionality to publish these granular documents into a single submission-ready document that can be added to an application via a simple drag/drop. Additionally, you will see an example of how LORENZ iSubmit creates a format from a file folder structure that can be imported into LORENZ docuBridge and repurposed.
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Strategies to Adopting Structured Data Submissions - Data Quality, Connectivity, and Governance
Steve Gens & Kelly Hnat, Gens and Associates, Inc.

While most companies have been doing preliminary planning ...
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Strategies to Adopting Structured Data Submissions – Data Quality, Connectivity, and Governance
Steve Gens & Kelly Hnat, Gens and Associates, Inc.

While most companies have been doing preliminary planning and strategizing on how to comply with IDMP/SPOR for years, the implementation clock is ticking and detailed planning, architectural strategy, data connectivity and quality decisions are front and center. Hear from two global experts on practical planning and strategy considerations and how to specifically improve data quality and connectivity in your organization.
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Technical Rejection Criteria for Study Data: Are You Ready?
Shannon Heacock, WAYS Pharmaceutical Services LLC

In October 2019, the FDA updated its technical rejection criteria ...
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Implementing the New FDA Technical Rejection Criteria for Study Data
Shannon Heacock, WAYS Pharmaceutical Services LLC

In October 2019, the FDA updated its technical rejection criteria for study data. The technical rejection criteria are automated validations that are run against inbound electronic submissions to the FDA CDER and CBER. They are part of their standard process for accepting electronic submissions. The validations are based on the FDA Specifications for eCTD Validation Criteria. They ensure that Sponsors are submitting standardized data in a CDISC compliant format when applicable for clinical and non-clinical studies. The relevant formats for clinical data are SDTM and ADaM. SEND is the compliant format for nonclinical data. New technical rejection criteria ensure that study data standards are being utilized when submitting clinical and non-clinical data.
This presentation will:

• describe the new technical rejection criteria for study data
• discuss the business case for the new criteria
• examine how they will impact regulatory submission processes
• recommend ways to minimize the impact of the new measures and ensure submission compliance

LORENZ Validation Services: How They Can Add Value For Our Customers
Leonhard Keller & Massud Fazelly, LORENZ Life Sciences Group

In this session, Massud Fazelly and Leonhard Keller will talk...
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LORENZ Validation Services: How They Can Add Value For Our Customers
Leonhard Keller & Massud Fazelly, LORENZ Life Sciences Group

In this session, Massud Fazelly and Leonhard Keller will talk about the validation services offered by LORENZ and how customers can use the services to minimize their validation efforts.
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RA Efficiency Through Process Optimization: A Bayer Case Study
Dr. René Klünsch, Anna Sahl, Dr. Ulrike Vollmer, and Jerianne Minervini, Bayer AG

"Digitalization" is a key success factor to enhance efficiency ...
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RA Efficiency Through Process Optimization: A Bayer Case Study
Dr. René Kluensch, Anna Sahl, Dr. Ulrike Vollmer, and Jerianne Minervini, Bayer AG

"Digitalization" is a key success factor to enhance efficiency in Regulatory Affairs. But what does that mean and how can this be achieved in real life? At Bayer we are convinced that successful digital transformation in RA requires the combination of advanced technology with optimization of processes. We launched the “BRAVE” initiative to overcome silos that span functions, processes, IT applications and even underlying data. Join us to hear about how we evaluate our current IT landscape, identify pportunities to work better, and embrace technologies to establish a set of Regulatory Affairs capabilities.
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Health Canada Updates
Irena Pastorekova, Health Canada

This session will give an update on Health Canada's ...
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Health Canada Updates
Irena Pastorekova, 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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Cloudy With a Chance of COVID - Regeneron's Journey to Implement LORENZ During a Global Pandemic
Robert Pers, Jim Czubachowski, Joseph Moy, and Vladlen Rotshteyn, Regeneron Pharmaceuticals, Inc.

This presentation is of the Regeneron journey to implement...
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Cloudy with a Chance of COVID - Regeneron's Journey to Implement LORENZ during a Global Pandemic
Robert Pers, Jim Czubachowski, Joseph Moy, and Vladlen Rotshteyn, Regeneron Pharmaceuticals, Inc.

This presentation is of the Regeneron journey to implement LORENZ in the AWS cloud during the Covid pandemic. After the conclusion of the in-person POC in Feb 2020 and then being told to work remotely from March 2020 on, we faced the unprecedented challenge of implementing a brand-new system in a completely remote and virtual way. This is the story of the opportunities and challenges we faced and overcame while delivering an industry leading solution to the business on-time and within budget.
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What's New in LORENZ docuBridge?
Kristina Roberson, LORENZ Life Sciences Group.

In this tutorial we'll discuss how ...
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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 20.2 and give you a sneak peak of the new features to be introduced in the newest version of docuBridge 21.1.
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LORENZ docuBridge for Advertising and Promotional Materials via eCTD
Jessica Romero, Melissa Andaya, Gilead Sciences, Inc.

Effective June 24, 2021, all required Promotional Labeling ...
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LORENZ docuBridge for Advertising and Promotional Materials via eCTD
Jessica Romero, Melissa Andaya, Gilead Sciences, Inc.

Effective June 24, 2021, all required Promotional Labeling and Advertising Material (Ad Promo) submissions described in the FDA guidance must be submitted in the eCTD format. This presentation will discuss the implementation of an efficient process to successfully submit Ad Promo submissions via eCTD to the FDA. In addition, this presentation will cover how to compile grouped submissions using Lorenz docuBridge, the steps to utilize the functionality of the system, and other helpful information when submitting to the OPDP or APLB divisions within the FDA.
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FDA and LORENZ docuBridge - Project Journey
Prasanna Sadashivaiah, LORENZ Life Sciences Group

During LORENZ Connect, learn about the FDA and LORENZ docuBridge project...
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FDA and LORENZ docuBridge - Project Journey
Prasanna Sadashivaiah, LORENZ Life Sciences Group

During LORENZ Connect, learn about the FDA and LORENZ docuBridge project journey from its inception through production rollout and beyond. We discuss the COVID-19 challenges encountered during project execution, the continuous change needed for success, and progressive leadership strategies that were implemented to meet the defined project go-live timeline. The main project goal was to transfer operations from the previous review tool to the LORENZ eCTD Review solution that can provide a better user experience and is a tool that can also scale up to the future business need. LORENZ implemented its docuBridge, eValidator and Automator solutions in FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) electronic submission programs. CDER and CBER are using the LORENZ product suite to validate and review both incoming and legacy eCTD submissions.
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Automation for Submissions
Dr. Katharina Schmitz, LORENZ Life Sciences Group

In the session, she will cover options for speeding up...
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Automation for Submissions
Dr. Katharina Schmitz, LORENZ Life Sciences Group

In the session, she will cover options for speeding up submission processed by removing the mundane, and underline the time savings that can be brought by automation for submissions. She will also help participants to understand the data quality needed for automation with submissions.
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They Asked for What? Bridging the Gap Between Reviewer Requests and eCTD Specifications
Gina Smith, United Therapeutics Corporation

As eCTD submissions become the norm, the instances of ...
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They Asked for What? Bridging the Gap Between Reviewer Requests and eCTD Specifications
Gina Smith, United Therapeutics Corporation

As eCTD submissions become the norm, the instances of a Reviewer requesting information from your company that does not fit nicely into the standard are becoming more commonplace. What do you do when the EMA asks you for datasets that you normally only submit to FDA? Or when they request a file type that isn’t accepted according to the Specifications? Or FDA requesting a post-market device AE submission to the NDA. During the table tutorial, I will discuss the out of specification requests we have received from FDA, Health Canada, and the EMA, and how we handled each.
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The Rise of the Chief Data Officer and Data Stewards: Fostering Reliable Data
Hans van Bruggen, Qdossier B.V.

During the past few years, more and more initiatives are related...
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The Rise of the Chief Data Officer and Data Stewards: Fostering Reliable Data
Hans van Bruggen, Qdossier B.V.

During the past few years, more and more initiatives are related to the exchange of data rather than documents, such as IDMP, PQ/CMC, FDA KASA, FDA GInAS/G-SRS, ePI, structured content management. In general, IT solutions can address all business rules. But the struggle is actually the lack of authoritative sources of the data. Integration of systems is also technically possible. However, inconsistent granularity of metadata and inconsistent terminology prohibits semantic interoperability. This made organizations aware that data granularity and terminology needs to be governed within- and across organizations. The difference between Big Data and the amount of data exchanged as part of regulatory information will also be addressed. The role of the CDO and Data Stewards is key for semantic interoperability and instant decision making based on data.
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Global Regulatory Updates
Akira Yamaguchi, LORENZ Life Sciences Group

The electronic submission topic has already...
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Global Regulatory Updates (EMEA, China, South Korea, Taiwan, China, US)
Akira Yamaguchi, LORENZ Life Sciences Group

The electronic submission topic has already a history of two decades and is often described synonymously as eCTD. Today they are specified for 14 regions in over 50 countries. The presentation focuses on recent updates in Asian regions and the FDA by highlighting conceptual particularities.
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LORENZ Roadmap & eCTD 4.0
Akira Yamaguchi, LORENZ Life Sciences Group

ICH's eCTD v4.0 was undergoing...
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Global Regulatory Updates (EMEA, China, South Korea, Taiwan, China, US)
Akira Yamaguchi, LORENZ Life Sciences Group

ICH's eCTD v4.0 was undergoing specification developments for many years and its continuation was questioned already. Around 18 months ago ICH recommended to move forward with the implementation and regional updates are available. The presentation describes the conceptual aspects of eCTD v4.0 and the implications to LORENZ's development roadmap.
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