ISPE GAMP CoP Benelux - Computerized systems and electronic data in clinical trials

29 May, 2024

On May 29th, ISPE GAMP Benelux got a warm welcome by UCB in Anderlecht during the event ‘Computerized systems and electronic data in clinical trials “. 

Thank you very much to UCB for being the host of this wonderful event! 

In total we welcomed almost 60 attendees, including a lot of new faces visiting an ISPE GAMP Benelux event for the first time, thank you all for being at the event!

During the event we had the following presentations:

  1. Welcome by GAMP Benelux & UCB: Natasja Bastiaens (ISPE GAMP COMP Chair) welcomed all the attendees and speakers. 
  2. Digitally Improving Patient Lives: Jan Vandenneucker (UCB) explained how UCB creates impact with digital business transformation on patients & stakeholders on two clear focus areas, Rare diseases and Epilepsy. 
  3. EMA Guidance on Computerized Systems and e-data in Clinical Trials in a nutshell: Natasja Bastiaens brought some highlights of the guidance which is effective since September 2023.
  4. New revised GAMP Practice on CSV in Good Clinical Practice: Oliver Hermann presented the drivers (Covid-19 pandemic), updates and new content on the GAMP Good Practice Guide on Validation and Compliance of Computerized GCP System & data, 2nd edition. 
  5. Clinical Trials Digital Solutions and their companies through the eyes of the Sponsor: Bart de Wolf (UCB)  guided the audience through the digital technologies used in  GCP in the past, today and in the future and how to transfer challenges into opportunities.   
  6. Clinical Trails Digital Solutions and their companies through the eyes of a CRO Perspective: Matthew Adams and Vanessa Vanessa Ciulli-Lasbordes (Icon) presented the Digital Health Technology from a CRO Perpective. The following topics were evaluated: data flow evolution from paper to digital, application of analytics to digital clinical data, regulatory requirements and innovation though analytics and data transparency. 
  7. How to conduct efficient IRT UAT: Henk Dieteren (Suvoda) guided us through the challenge of developing and execution of proper User Acceptance Testing based on the User Requirements related to an IRT (Interactive Response Technology) solution.  
  8. Q&A to all speakers: Natasja Bastiaens facilitated the Questions & Answers sessions in the event, all speakers were available in the answering the questions from the attendees, it was very inter-active and provided us new insides related to Computerized systems in Clinical trials. 

At the end UCB offered all participants a delicious walking dinner, with warm, cold dishes and drinks, which gave us all the opportunity to reflect with the peers.  

As follow-up of this successful event, a Knowledge Café to the same topic ` Computerized Systems and e-data in Clinical Trials` on July 3rd .