Ginas Workshop Uppsala , September 7-8, 2015
Chair Malin Jakobssoen, Uppsala Monitoring Center (UMC)
Chair Noel Southel, National Center for Advancing Translational Sciences at the National Institute of Health (NIH/NCATS)
GINAS Workshop Uppsala was fully booked with 80 participants and even more taking part online.
UMC and the National Center for Advancing Translational Sciences at the National Institute of Health (NIH/NCATS) have hosted a two-day meeting on the GINAS initiative and its Global Substance Registration System (G-SRS) software in Uppsala Sweden.
This meeting has addressed both scientific and information technology aspects of defining, registering and linking essential information related to substances in medicinal products.
Day 1 started with a more technical overview of the GinAS project, followed by a demonstration of the new GINAS version, which will be available for testing purposes in November 2015. The November seed´s data codes round about 160.000 codes, 485.000 names, 73.000 relationships between substances (like metabolites, impurities etc.).
Day 2 was more on expert topics like plants, blood products, vaccines and advanced therapeutic medicinal products.
FDA will implement the new SRS Ginas Software at FDA in the second quarter 2016.
I had a lot of hair starting the IDMP program at Astellas.
Allotrope Foundation is focused on the analytical data needs of the community.
“HokuspokusBob” is not a valuable name. Changing the genus means to change the name.
Presentations by FDA and EMA along with questions from the audience left the impression that much work is being done and many decisions still needs to be taken, but things have gotten off the starting blocks. There where critical input in respect to timelines and lack of available information given the current timelines. From my perspective the participants of this GINAS workshop would have liked to discuss more in detail these challenges.
All presentations from the GINAS workshop can be accessed here .
Goal for the meeting was to update and align efforts currently underway by implementation guide participants, FDA, EMA, industry, vendors, and other important stakeholders. And this was efficiently reached by excellent speakers, a perfect organisation of this conference and last but not least – the feedback and input from the audiance.
Test GINAS online
GINAS provides a common identifier for all of the substances used in medicinal products. It is a collaboration of several national agencies concerning the content. The software is open-source and the use is free. GINAS provides a wide range of APIs.
An online impression of the new GINAS user interface is available here
Even though it was hard to get home because of the Lufthansa strike: It was an awesome workshop – a big warm thanks to the team at UMC and NIH/NCATS for that!