Stephen Thompson, Director of Regulatory Affairs, is in the USA this week and it’s just over a month until our CDISC Team will be at the European Interchange.

Regulatory Affairs in the USA

In case you missed it, Stephen Thompson is currently in the USA meeting clients in San Francisco Bay area this week, travelling south through Orange County and to San Diego next week. He will be presenting at the San Diego Regulatory Affairs Network meeting on Wednesday 28th March. If you need to know about the current regulatory framework in the EU, please be sure to attend the meeting. Full details here.

Our CDISC Team

It’s just over a month until the CDISC European Interchange, in Berlin and it seems appropriate to highlight our expert consultants at this time.

We were pleased announce that Johannes Ulander has now been recognised for his expertise in the SDTM model and is now a CDISC Authorised Instructor for SDTM Theory and Application. Johannes is a Principal Consultant at S-Cubed focusing on standardization and standards governance, helping clients to create sustainable CDISC deliverables. Before joining S-Cubed, he was the SDTM Development Team Lead, leading a global team of SDTM experts at AstraZeneca for standards in the organization. The work included governing, developing and implementing SDTM standards within the company, as well as contributing to other standards development internally to have an end-to-end alignment when moving towards more CDISC adaption. He is a member of the CDISC Definitions Team.

Johannes is also part of the team delivering the Glandon Suite developed by A3 Informatics and is an expert in Linked Data and Graph Technologies. You can meet Johannes at the CDISC Interchange on our stand or you can attend his presentation on Thursday during Session 6 at 1100 – 1200 in Track B, Utilising CDISC. Always one to challenge the way that we work, Johannes’s presentation on ‘Where did my Terminology Go?’ will consider the way we are using Controlled Terminology and how we, as an industry maintain consistency when updates are regularly announced.

You can also meet Kirsten Langendorf at the CDISC Interchange, where she will be available on our stand to answer any of your questions. You can read more about Kirsten over on the Our Stories page, as she is our featured member of staff this month. Finally Carey Smoak, will be presenting his poster on ‘A Critique of the Use of Medical Device SDTM Domains in Therapeutic Area User Guides’. Come and meet Carey to discuss any issues relating to Medical Devices.

S-cubed would not have the wealth of CDISC knowledge and expertise without Niels Both, S-cubed Partner and Data Standards Implementation Specialist is also an Authorised CDISC Instructor for the ADaM Primer, ADaM Theory and Application and SDTM Theory and Application. Having worked for more than 15 years within the different areas of clinical data flow ranging from collection to statistical analysis and submission, Niels Both provides training in CDISC standards, coupled with a unique understanding of the everyday problems encountered when submitting data in SDTM, define.xml or ADaM to FDA. For the last 10 years, Niels has been assisting companies across Europe implementing CDISC standards, end-to-end ranging from CDASH over SDTM to ADaM. You can contact Niels here.