Insights on the New ADaM guidelines and Europe Interchange 2022
April 25, 2022
I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual event (hopefully, for the last time). The program designed by the CDISC Europe Committee and the CDISC team looks promising as always! Silvia Faini and I (members of the committee) will lead the “Tech-Enabled Standards” and “ADaM” streams, respectively.
This year, in addition to the customary keynote presentations, updates from the regulatory agencies, which includes the EMA “Raw Data Project”, and other announcements, there is going to be a dedicated stream for the CDISC Core (CDISC Open Rule Engine) Project. This will be followed by a workshop on April 29, dedicated to the CDISC Open-Source Alliance (COSA), a CDISC initiative to support and promote open-source software projects that create tools for implementing or developing CDISC standards (see also, the current COSA Repository Directory https://cosa.cdisc.org/).
Several sponsors, CROs and academic organizations will share their experiences during the event. Cytel’s Principal Statistical Programmer, Silvia Faini will present on “ADaM Traceability and Multiple Imputations” where she will discuss how to achieve traceability in ADaM, particularly when you need to implement complex Multiple Imputations. You can join me at Session 6C: CDSIC Foundational “20 Minutes to get you aligned with new ADaM IG (et al)”, where I will introduce the most recent updates on the CDISC ADaM standard with the presentation. The focus of my presentation will be on the ADaM update:
- ADaM Implementation Guidance Version 1.3
- ADaM OCCDS Implementation Guidance Version 1.1
- ADaM Implementation Guidance for Medical Device Version 1.0
- ADaM Implementation Guidance for Non-Compartmental Analysis Version 1.0
Silvia and I are looking forward to meeting you all there. Click here, for more information on the conference.
Over the years, I have written several blogs on my experience with data submission and data integration such as ISS and ISE. Click here to download Cytel’s eBook where I share critical insights on clinical data standards submission.
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Angelo Tinazzi
Senior Director, Statistical Programming, Clinical Data Standard & Submission
Angelo Tinazzi is Senior Director, Statistical Programming, Clinical Data Standard & Submission, at Cytel. Angelo is a well-published and recognized expert in statistical programming, with over 25 years’ experience in clinical research. In particular, his core expertise lies in the application of CDISC standards across different therapeutic areas, such as data submission to health authorities like the FDA and PMDA.
As well as being an authorized CDISC instructor, Angelo is member of the CDISC European Committee, where he also manages the Italian-speaking CDISC User Network. Angelo is also stream chair of PHUSE-EU “Scripts, Macros and Automation.”
Prior to joining Cytel, Angelo worked at Merck Serono, SENDO Foundation, Phamarcia & Upjohn, Simbologica SAS Quality Partner, the UK Medical Research Council, and the Institute for Pharmacological Research “Mario Negri.”
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