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IDMP events

Ginas Meeting June 27th 2018 – Agenda and Webex

Ginas Meeting June 27th 2018 – Agenda and Webex

Reminder the next Ginas Meeting June 27th 2018. This meeting is fully public and anyone is welcome to attend. Please forward this meeting invite to any interested parties.

Here is the agenda:
• Status update of GSRS 2.2 release and what is planned in 2.3 release (Danny Katzel and Tyler Peryea)
• Windows support of GSRS (Danny Katzel and Tyler Peryea)
• Public data version of FDA-GSRS (Larry Callahan and Frank Switzer)
• Current situation of the EU-SRS project. (Frits Stulp)
• Discussion of current examples in the NCATS-SRS cloud. (Herman Diederik)
• Proposals of integration SSG2 and SSG3 ISO models for use in FDA-EU-SRS. (Herman Diederik)
Webex details below:
You can forward this invitation to others.

Starting Time

GSRS June Meeting
Wednesday, June 27, 2018
10:00 am | Eastern Daylight Time (New York, GMT-04:00) | 2 hrs

Meeting number (access code): 626 326 294

Meeting password: Js525YBA

When it’s time, join the meeting.

 

IMPORTANT NOTICE: Please note that this WebEx service allows audio and other information sent during the session to be recorded, which may be discoverable in a legal matter. By joining this session, you automatically consent to such recordings. If you do not consent to being recorded, discuss your concerns with the host or do not join the session.

ISO IDMP Workshop, 14 November 2016, Lillehammer, Norway

We are very pleased to inform you that the 3rd edition of the IDMP Workshop will take place on Monday 14th November in Lillehammer, Norway. The invitation and agenda for the Workshop is attached for your consideration of which we would emphasize the interest to participate for interested experts from Scandinavia, in particular from pharmaceutical companies and regulatory agencies.

Please note that registration must take place via: https://www.xing-events.com/IDMP-Norway and a registration fee of €100,- is requested for non-ISO members to cover the costs which are invoiced by the meeting venue, Hotel Lillehammer.

Report on the GINAS Workshop Uppsala

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.

Vada Perkins, FDA
Vada Perkins, FDAU.S. FDA Activities: ISO IDMP

I had a lot of hair starting the IDMP program at Astellas.

Frits Stulp, IPERION
Frits Stulp, IPERIONAstellas Preparations toward IDMP Compliant Substance Management

Allotrope Foundation is focused on the analytical data needs of the community.

Gerhard Noelken, Pfizer
Gerhard Noelken, PfizerAllotrop Initiativ

“HokuspokusBob” is not a valuable name. Changing the genus means to change the name.

Bob Allkin, KEW Royal Botanic Gardens
Bob Allkin, KEW Royal Botanic GardensIdentification of plants in commerce

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

Thank you!

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!

160.000

GINAS codes

485.000

substance names

83.000

substance relations