Posted on September 16, 2021
Wolfgang Witzel, Amirhossein Mousavi, Simone Ufert, Manuel Stein
What would you have done if a 15-year-old refugee had applied for a full-time position in software development at your company? At first, we were also surprised about the application. But after having looked through his documents, we became curious and knew that we really should get to know this young person, especially with this résumé:
Posted on September 1, 2021
Posted on August 19, 2021
The year 2021 is a landmark one for IDMP implementation. After version 2.0 of the EU IDMP guide came out in February, version 2.1 of the implementation guide was released on 30 June. This now leaves only version 2.2 in the pipeline; currently anticipated in Q3 of 2021. After that, depending on the outcomes and learnings from step 1 of the TOM (Target Operating Model) implementation, version 3.0 of the EU IDMP guide will be published to support step 2.
Version 2.1 of the EU implementation guide now covers the following chapters and content:
This entry was posted in Regulatory Affairs News.
Posted on July 30, 2021
News from the LORENZ Charitable Foundation
The Summer Paralympics in Tokyo are only 4 weeks away (24 August) and our “golden boy” Vico Merklein is using his preparation for this next highlight in his career to support the charity run “Together around the world” by the UKE Hamburg (University Medical Center Hamburg-Eppendorf). Our LORENZ Charitable Foundation will donate money for every kilometer cycled by Vico. The 100-day UKE benefit run is dedicated to child protection in Hamburg and all proceeds will benefit children who are looked after at the children's competence center at the UKE in the event of domestic violence such as neglect or sexual abuse. The money donated by the LORENZ Charitable Foundation will go towards maritime equipment for children, such as a boat, beach chairs, ropes to learn knots, and much more. The aim of the charity run is to run, cycle, or swim the circumference of the earth along the equator, which corresponds to a distance of 40,075 kilometers. Thanks to people like Vico Merklein, this goal has already been surpassed, even though there are still 30 days left! More information on this project can be found here (in German).
Two LORENZ customers have created a working group on issues related to agency guidelines and are intending to expand this user group to include docuBridge more generally. We are happy to share their announcement, and invite our customers to consider joining this independent user forum:
Posted on June 11, 2021
In January 2020 Health Canada notified industry of their plans and timelines to start transitioning product monograph templates into a structure format based on XML, HL7 Structured Product Label (SPL) standard and controlled vocabularies. Phase I was initiated by Health Canada in June 2020 for production testing in which sponsors could submit requests to participate. This phase helped ensure that both Health Canada and industry systems were functioning as expected.
This entry was posted in LORENZ Solutions and Services.
Posted on May 25, 2021
As a company, we at LORENZ regularly think outside the box of our daily business. This is also reflected in the ongoing conversation series which has been organized by LORENZ since the late 80s. Special guests have included former chancellors, government ministers, and prominent authors. Instead of hosting such an event on-site at our headquarters in Frankfurt, we have continued the series online.
Posted on May 19, 2021
The second LORENZ Connect virtually hosted participants from 25 countries as they tuned in to listen to global experts and health authorities discuss recent trends and topics affecting the Regulatory Affairs World today. With 27 speakers from all over the world, a wide variety of hot topics were covered in 18 sessions, including the technical rejection criteria for study data, RA efficiency through process optimization, global regulatory updates, and Health Canada updates. The conference began with a keynote address by our CEO Raoul-A. Lorenz, in which he presented LORENZ's achievements to date, the principles we strive for, and what's coming next. He underlined our ambition to offer you one seamless and flexible user experience by showing the new LORENZ Application Suite, which combines all of our business capabilities into one platform.
This entry was posted in LORENZ Events.