This year’s userBridge conference in Athens, Greece is already sold out!
As a registered participant, you can look forward to a wide range of regulatory affairs perspectives from agencies, industry and prominent consultants.
Established under the overall theme “Learn, Discuss and Interact”, the conference covers a wide variety of presentations and tutorials focusing on practical solutions for current challenges regulatory and IT professionals face. Find here two interesting abstracts which you can find on this year’s agenda.
For the final LORENZ userBridge 2019 agenda please click here.
Update on eCTD for China
In summer 2017, China was approved as the eighth regulatory member of the ICH. Since then, China’s regulatory landscape has undergone a transition of incredible scope and speed. A draft specification was published in March 2019, and we expect the launch of eCTD in December.
The eSubmission Roadmap v2.2 has recently been updated by the HMA. The purpose of the roadmap is to provide a high level strategic plan for business and technology changes over several years, and is meant to help NCAs, EMA and pharmaceutical industry prepare themselves for the forthcoming changes. Many of the adjustments are likely due to the EMA’s relocation.
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)
The April releases of docuBridge, drugTrack and eValidator are available!
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
In November 2018, we released a press release regarding the Chinese NMPA, noting that the agency selected our docuBridge and eValidator solution as an eCTD data management system. Now, the next step has been taken towards introducing eCTD submissions in China.
The CDE of the NMPA published the Chinese eCTD specification on March 1, 2019. Comments are appreciated until April 1, 2019. This marks an important milestone in China´s eCTD project, beginning the countdown to the final implementation of eCTD submissions in China.
Because of our involvement in this project, we can offer our customers around the world a head start in meeting China´s new eCTD submissions requirements. Please feel free to contact us or ERIS, our distributor for LORENZ e-regulatory affairs solutions in mainland China, regarding inquiries and further collaboration.
The original packaging of the eValidator 18.2.1 release shows a false negative for US eCTD rule 5030.
To correct this, we have just updated the eValidator 18.2.1 setup, which is available for download immediately. If you installed the package before February 4, 2019, please download and install the latest version or run a repair installation in the Windows control panel to resolve the issue. Continue reading
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