Since June 1, 2018, the National Competent Authorities no longer accept veterinary submissions for Centralized Procedures via CD, DVD or Eudralink. This means that the EMA eSubmission Gateway / Web Client is now the only route for VNeeS submissions. Continue reading
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!
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.
The October releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Multiple user-friendly improvements have been made. Configurable column layout settings in the submission Continue reading
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.
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.
Several anti-virus scanning programs have started to report that installed docuBridge software (version 5.10 or higher) is infected with viruses or malware. Please note: Continue reading