Visualizing STF Content in a Browser Using the ICH Stylesheet

Currently we are receiving many support questions regarding an issue that arises when displaying STF study reports in a browser using the new stylesheet version 2-3. We would like to explain the background and why we need to wait until ICH issues another official stylesheet to correct this.

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LORENZ docuBridge, eValidator, and Automator making their debut at the USFDA

The LORENZ implementation team was on-site at the USFDA headquarters in Silver Spring, Maryland between April 30 and May 4, 2018, to discuss the implementation process and to begin the training of agency personnel in LORENZ solutions within its RIM portfolio.
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International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.

Introduction
In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.

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LORENZ Changes Its Release Naming – Unified release naming system starting in April 2018

We are switching to a unified release naming system for all of our products, based on the calendar year.

The year-based nomenclature makes sense as LORENZ products become more and more integrated – acting as interlocking components in a single Regulatory Information Management suite. The new naming convention also follows best practice in the industry, and will help increase clarity on which version of each product is the most current – especially for customers who are using two or more LORENZ solutions in integrated environments.

For a detailed explanation of the new naming system, please click here.

To stay informed about both major and minor releases, please subscribe to Product & Service Update Announcements in your LORENZ ID.