CONNECTING PHARMACEUTICAL KNOWLEDGE

Computerized systems and electronic data in clinical trials

Computerized systems and electronic data in clinical trials

Join us on May 29th, 2024 at UCB, Anderlecht (BE), for an exciting GAMP event on “Computerised systems and electronic data in clinical trials”. This event will focus on real use cases to inspire you with your future implementations. Learn from experts in the field about computerized systems and e-data in clinical trials and use their knowledge to improve your quality, efficiency, and safety. Our speakers will talk about:

  • Technology Companies / Cloud solutions in Clinical Trials;
  • Guidelines on electronic data in Clinical Trials;
  • Revised GAMP Good Practice Guide on CSV in Good Clinical Practices;
  • Epilepsy: Seizure detection and prediction, and digital health initiatives.

This meeting will also feature a Q&A session where attendees will have the opportunity to ask questions and gain valuable insights from experts. Don't miss out on this opportunity to network with industry leaders and gain a deeper understanding on the future of the life sciences industry. Register now on our website and be at the forefront of innovation!

  • This event is held at UCB, Researchdreef 60, 1070 Anderlecht, Belgium, who are so kind to sponsor the facilities, drinks, and food.
  • The event on 29 May 2024 starts at 13h30 and ends at 19h30.
  • Car parking: you can easily park at the parking place at Decathlon (10 mins walk) or come to the event via Public Transportation (metro / bus) (see Location)

The event is open for both ISPE members (free of charge) and non-ISPE members (€40). Registration is required.

Event Properties

Event Date 29-May-2024 13.30
Capacity 80
Registered 57
Individual Price €40.00
Location UCB

Agendas

13:30

Welcome & Registration

14:00

Welcome - GAMP CoP Benelux

GAMP CoP Chair Natasja Bastiaens

14:05

Introduction of sponsor UCB

Sylvie Rauel Rasmusse (UCB)

14:15

Digitally Improving Patient Lives

Jan Vandenneucker (UCB)

14:55

Guideline on computerised systems and electronic data in clinical trials in a nutshel

Natasja Bastiaens (UCB)

15:15

New revised GAMP Practice on CSV in Good Clinical Practices

Oliver Herrmann (Q-Finity)

15:45

Break

16:15

Clinical Trials digital solutions and their companies through the eyes of the sponsor

Bart Dewolf (UCB)

16:45

Clinical Trials digital solutions and their companies through the eyes of a CRO

Vanessa Ciulli-Lasbordes (Icon Fr) and Matthew Adams (Icon UK)

17:15

How to Conduct Efficient Interactive Response Technology UAT

Henk Dieteren (Suvoda)

17:45

Q&A

Get answers on your questions, and discuss with peers

18.25

Wrap-up & closing

Natasja Bastiaens (GAMP CoP Benelux Chair)

18:30

Diner / networking

Kindly sponsored by UCB. Please sign up for dinner at registration, so no good food is wasted! Thank you.

19:30

End

Speakers

Henk Dieteren

Clinical Supply Solutions Consultant

Henk worked at the clinical supply chain at Grünenthal, BioNTech and Suvoda. Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.

Jan Vandenneucker

Neurology Digital Strategy & Project Lead

Jan is focused on defining where digital health solutions can create value for the patient populations in which UCB is or aspires to be present. Jan is an experienced project lead, strategist, and technology architect for digital health concepts and initiatives in the field of neurology.

Vanessa Ciulli-Lasbordes

Manager Clinical Data Risk Management

Vanessa has >15 years of CRO industry experience of which the past 7 are in a Clinical data Risk Management role. Responsible for the oversight of clinical data, including risk based central monitoring strategies, KRI identification, advanced analytical design.

Matthew Adams

Director Clinical Data Science

Matthew has >15 years of CRO industry experience. As Account Group Head -Operational delivery and strategic oversight, he is driving innovation within CDS in areas such as Machine Learning, Spotfire visualizations, and Audit Trail review.

Oliver Herrmann

Founder and Managing Director of Q-FINITY Quality Management

Oliver is a Qualified ISPE GAMP trainer, and chairman of the GAMP DACH Steering Committee.

Natasja Bastiaens

GAMP COP Benelux Chair

Natasja is the chair person for this meeting and currently working as IT Compliance Lead at UCB.

Bart Dewolf

Head of Technology Auditing and Compliance

Experienced in the Biotechnology and Medical Devices sector with a good knowledge of the current guidelines, standards and regulations used in the pharmaceutical and medical sector regarding validation activities for QA and compliance. Extended experience in project management.

Location Map