Category Archives: LORENZ News

This category includes information regarding LORENZ that are not fitting into one of the other LORENZ categories.

LORENZ Charitable Foundation: Grand finale of the inclusion project “Noah’s Ark”

Today we are proud to report on something that is not connected to Regulatory Affairs, but still means a lot to us: the inclusion project “Arche Noah” (Noah’s Ark) by the LORENZ charitable foundation.

After 9 months of rehearsals, the project had its barnstorming finale with a live performance in front of 800 people on May 22 in Frankfurt, Germany. Tickets were sold out weeks ahead of the show.

This initiative integrated multiple generations and people both with and without disabilities, and also transcended social class. Working together, this highly diverse group of 200 people thrilled the audience with dance and music in a variety of styles including classical – played live by the famous Frankfurt Radio Symphony – as well as pop, hip-hop and flamenco. Under the theme “Together we can move the world,” the project picked up on the challenges humankind is currently facing and connected them with the story of Noah’s Ark showing: we’re all in the same boat.

A moment the participants and the audience will not soon forget: singing the theme song “Together we can move the world” using sign language. (Picture (c)Lisa Farkas)

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The 19.1 releases of docuBridge, drugTrack and eValidator are available!

The April releases of docuBridge, drugTrack and eValidator are available!

Release Highlights:

What´s new in docuBridge? Several improvements come with release 19.1. An enhanced page scaling option for print and other publishing formats is available, and more granular permission settings for administrators. Continue reading

We wish you a reflective, joyous holiday season and a happy new year!

As 2018 draws to a close, all of us here at LORENZ would like to wish you a joyous holiday season and a very happy new year!

To celebrate the festive season, we are making a donation to the LORENZ Foundation to support their social work; in particular their “Arche Noah” inclusion project. Continue reading

LORENZ docuBridge, eValidator and Automator implementation progressing at US FDA – Preparing to migrate 1.3 million eCTD sequences

In response to questions about our ongoing implementation project at the US FDA, we would like to share a short update with you.

In our previous blogpost, we announced the need to migrate approximately 1.3 million legacy eCTD sequences into our docuBridge solution and make them available to US FDA reviewers.

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International Trends in Drug Registration and Evaluation [Part 3: ISO IDMP and the MPID]

Summary of part 1 and 2:

In our last blog posts of the series you were informed about eCTD v3.2.2 and eCTD v4.0. The articles resolved around the advantages of eCTD v3.2.2 over paper or non-eCTD electronic submissions and the improvements from eCTD v4.0 over eCTD v3.2.2. If you have not read it, you will find the first article here and the second article here.

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RAPS – Intermediate Course for Regulatory Submissions in eCTD Format

RAPS has once again chosen LORENZ to support their intermediate-level training workshops. Here, our LORENZ docuBridge solution is being used to illustrate the eCTD concept in detail, with discussions led by members of LORENZ and Mentara Inc.. The collaboration on RAPS workshops has been running since 2012.

Two of the three planned workshops in 2018 have already been completed; the first in San Diego, CA during April and the second in July in Rockville, MD. San Diego will also host the third training this coming November.

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