From: 11 May 2021 | To: 12 May 2021 | Location: ONLINE
Join our second LORENZ Connect online conference, this time with a focus on North America.
The virtual conference will be held on May 11-12, 2021.
Updated start time:
Click here for the full Agenda with session timeslots.
Please find below some of the exciting topics our regulatory experts will cover.
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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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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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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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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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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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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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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Health Canada Updates
Irena Pastorekova, Health Canada
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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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What's New in LORENZ docuBridge?
Kristina Roberson, LORENZ Life Sciences Group.
In this tutorial we'll discuss how ...
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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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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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Automation for Submissions
Dr. Katharina Schmitz, LORENZ Life Sciences Group
In the session, she will cover options for speeding up...
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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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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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Global Regulatory Updates
Akira Yamaguchi, LORENZ Life Sciences Group
The electronic submission topic has already...
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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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Email contact: www.lorenz.cc/email