European CDISC Coordinating Committee

European CDISC Coordinating Committee

Malathi Hari

Programming Manager, Data Science, Larix A/S

E3C Members: Andrea Rauch (Boehringer Ingelheim), Stijn Rogiers (SAS), Angelo Tinazzi (Cytel), Simon Lundberg (AstraZeneca), Éanna Kiely (ClinBuild), Nick De Donder (Business & Decision Life Sciences), Joerg Dillert (Oracle), Jozef Aerts (XML4Pharma), Silvia Faini (LivaNova), Malathi Hari (Larix), Sujit Khune (Novo Nordisk)



The 2020 CDISC European Interchange will be held in Berlin, Germany returning to the Titanic Chausse Hotel, the same great location from 2018. The conference takes place 1— 2 April, earlier than other years.

Call for abstracts is already open; submission deadline is 29 November 2019. We encourage you to share your expertise by submitting an abstract.

The E3C team met at the LivaNova office in Milan on 30 August to start planning for the upcoming CDISC conference. Thank you LivaNova for hosting us: Milan is without doubt one of the most beautiful cities in the world.

Meeting topics included feedback from last year’s CDISC conference, new ideas for the upcoming event, keynote presentations, regulatory sessions (including China submission), coordinating with local user groups and promotions.

Topics for the Call for abstracts were discussed and here are few interesting ideas for the abstracts/presentations

  • International submissions
  • CDISC 360 updates
  • Latest CDISC standards: SDTM v3.3, DefineXML v2.1
  • Different validation Rules and validator tools
  • FDA guide and FDA CDRH experience/updates/application as medical devices use changed in the last years
  • Experience with TAUGs and more examples of Use cases
  • MDR session and Metadata guide v2.0
  • Standards governance and Handling CDISC versions before submission/across standards
  • Real World Evidence
  • Efficiency of standards usage / Management KPIs
  • Artificial Intelligence / Mobile devices
  • it would be great if CDISC or FDA can make a presentation on safety endpoints of MACE, which is part of CDISC 360
  • Laboratory and LOINC codes
  • CDISC Library API
  • Any CDISC model experience, its implementation and associated planning. Related use cases are encouraged.

New proposals for upcoming conference include the following

  • Network and break-out: taking topics from the conference, instead of panel discussion, with CDISC representative participating in the discussion
  • CDISC standards usage in academia

New proposals for next year’s conference include:

  • Network and Break-out: Taking topics from the conference, instead of panel discussion, with CDISC representative participating in the discussion
  • CDISC Standards Usage in Academia

Session chairs have been assigned to the streams and the groundwork has started.

The next E3C meeting will take place at the AstraZeneca office in Gothenburg on 4th-5th December to select the presentations.

The E3C and CDISC Events Team are looking forward to receiving your abstracts! We invite new people to join E3C team; those interested can find more information here.

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