Posted on July 29, 2022
Transformative changes related to submission management has become a popular discussion in many global forums over the past few years. This has primarily been fuelled on by the pandemic and the realization that modernization in regulatory practices and frameworks is vital to keep up with the needs of tomorrow.
Drug submissions continue to shift towards standardized formats and increase in volume, complexity. We have seen an evolution from uncontrolled paper to a broader global use of electronic Common Technical Document (eCTD) over the past years.
Posted on July 15, 2022
Since the Covid pandemic started we have been longing for this moment and can’t wait for our on-site conference to take place and finally meet you all in person once again. This year’s LORENZ Converge, our successor of userBridge and LORENZLink, will take place September 13-14 in Brussels, Belgium.
Posted on May 23, 2022
Our third LORENZ Connect conference has come to an end. We would like to thank all of our speakers for the time and effort in preparing and giving their presentations, as well as everybody who tuned in to the event.
Posted on April 29, 2022
What's new in docuBridge? The ‘Jobs’ page in the adminPanel has been fully reworked to increase usability and functionality, making it easier to analyze the search results of your jobs. Context-sensitive toolbars have been added to the webAccess Explorer and the webAccess Submission Workbench to make accessing the available functions more convenient. Managing access permissions to the storage locations have also been centralized. Click here to read more about these highlights: What's new in docuBridge 22.1?
Posted on April 8, 2022
Our third LORENZ Connect is just around the corner. Customers, health authorities and consultants can join this online event for free on May 17 and 18. As our last two virtual conferences have shown, there is strong worldwide interest in recent Regulatory Affairs trends. Last year’s event drew participants from 25 countries and this time, we hope to attract an even broader range of attendees.
Posted on March 10, 2022
Since the EMA has changed the ISO IDMP timeline in order to push the Digital Application Dataset Integration Project (DADI), we want to offer you an overview of what has changed and the reasons behind it.
This entry was posted in Regulatory Affairs News.
USFDA eCTD 4.0 technical pilot – test environment will be available in May for interested LORENZ customers
Posted on February 28, 2022
LORENZ is globally involved in conceptual and technical activities for the implementation of eCTD 4.0 functionalities. The USFDA is now planning a testing phase for eCTD 4.0 during this year, and we will be giving our customers the opportunity to access a test environment to participate in the pilot phase.