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 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 | 50 |
| Registered | 50 |
| Individual Price | €40.00 |
| Location | UCB |
Agendas
| 13:30 |
Welcome & Registration |
| 14:00 |
Welcome - GAMP CoP BeneluxGAMP CoP Chair Natasja Bastiaens |
| 14:05 |
Introduction of sponsor UCBSylvie Rauel Rasmusse (UCB) |
| 14:15 |
Digitally Improving Patient LivesJan Vandenneucker (UCB) |
| 14:55 |
Guideline on computerised systems and electronic data in clinical trials in a nutshelNatasja Bastiaens (UCB) |
| 15:15 |
New revised GAMP Practice on CSV in Good Clinical PracticesOliver Herrmann (Q-Finity) |
| 15:45 |
Break |
| 16:15 |
Clinical Trials digital solutions and their companies through the eyes of the sponsorBart Dewolf (UCB) |
| 16:45 |
Clinical Trials digital solutions and their companies through the eyes of a CROSinead Clarke (Icon) |
| 17:15 |
How to Conduct Efficient Interactive Response Technology UATHenk Dieteren (Suvoda) |
| 17:45 |
Q&AGet answers on your questions, and discuss with peers |
| 18.25 |
Wrap-up & closingNatasja Bastiaens (GAMP CoP Benelux Chair) |
| 18:30 |
Diner / networkingKindly sponsored by UCB. Please sign up for dinner at registration, so no good food is wasted! Thank you. |
| 19:30 |
End |
Speakers
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.
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.
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.
Sinead Clarke
ICON
Sinead Clarke is a Senior Director from ICONs eClinical Development and Delivery group. Sinead is based in the UK. She is very familiar with late phase clinical development activities. Her previous role was Director Operations in RWS.