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Lorenz Events

LORENZ Connect

From: 11 May 2021 | To: 12 May 2021 | Location: ONLINE


Persevering With Purpose During a Pandemic

Join our regulatory affairs experts 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:

11:30am EDT / 8:30am PDT / 5:30pm CEST, May 11
11:00am EDT / 8:00am PDT / 5:00pm CEST, May 12.


Customers, partners, and interested parties from the regulatory affairs industry and health care agencies are welcome to join us - completely free of charge! All you'll need is your LORENZ ID.

Click here for the full Agenda with session timeslots.

Please find below some of the exciting topics our regulatory experts will cover.

AGENDA HIGHLIGHTS

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


This session will give an update on Health Canada's ...
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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

LORENZ Roadmap & eCTD 4.0
Akira Yamaguchi, LORENZ Life Sciences Group

Email contact: www.lorenz.cc/email

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