EVENTS info session: "Real world evidence" - November 8th, 2019

09:30 - 16:30
Dolce La Hulpe, 1310 La Hulpe, Chaussée de Bruxelles 135, Belgium
Info session Real world evidence

Real world evidences have become key for innovative drugs during research and their life cycle, to the benefit of the patients and the sustainability of our healthcare system. During this day, we would like to present various accessible databases with Belgian health data. The data owners will explain the databases (content, structure, data that could be delivered to pharma companies...) and the concrete procedure to request the data. Also some companies will share their experience with the databases.

It will be a very practical, hands-on info session on available real-world-data in Belgium. info session: "Real world evidence"

09:30 - 09:35
Introduction Speakers : Mrs Mrs. Karen Crabbé
Economic and Health Data Expert at
Mrs Mrs. Julie Gusman
Senior Market Access Expert at
09:35 - 11:05
NIDHI - During the first session, the different databases and procedures for data collection at NIDHI will be presented, with some concrete examples.

How to structure a chapter IV/VIII to facilitate data collection?

  • NIDHI guidance (Virginie Millecam, NIDHI)
  • Some recent examples (Ellen Vanhaeren Biogen, Caroline Hoefkens Amgen, Marie-Laure Leto Novartis)

Technical platform for chapter IV/VIII

  • CIVARS (Virginie Millecam, NIDHI)
  • TARDIS 1.0 (Patrick Verschuren KULeuven)  

Data from DocPH & Pharmanet

  • Introduction by NIDHI (Virginie Millecam, NIDHI)
  • User case using docPH (Jan Vertriest, MSD)

Q&A NIDHI data

Speakers : Mrs Mrs. Virginie Millecam
Advisor (Expert) & Secretary CRM - NIDHI
Mrs Mrs. Ellen Vanhaeren
Associate Director Market Access & External Affairs - Biogen
Mr Mr. Jan Vertriest
Health Policy Manager - MSD Belgium
Mrs Mrs. Caroline Hoefkens
Value & Access Manager - Amgen
Mrs Mrs. Marie-Laure Leto
Head Market Access & Customer projects Oncology - Novartis
Prof Prof. Patrick Verschueren
Professor of Rheumatology - KU Leuven
11:05 - 11:20
Coffee break
11:20 - 11:50
IMA data. IMA will explain the procedures, templates and timelines of the administrative data of the Belgian Healthcare system. They will also go into the potential issues and possible connections with other databases.
  • IMA: Use of real world data in the context of conventions/Individual revisions (Carine Pochet, Koen Cornelis, IMA)
  • Q&A IMA data
Speakers : Mrs Mrs. Carine Pochet
Data Manager - IMA
Mr Mr. Koen Cornelis
Data Analyst - IMA
11:50 - 12:20
General Belgium Statistics
  • Presentation of the Belgian population statistic database, eg mortality registry per disease (Patrick Lusyne, Statbel)
  • Q&A Belgium statistics
Speaker : Mr Mr. Patrick Lusyne
Data Expert - Statistics Belgium
12:20 - 13:20
13:20 - 14:15
Healthdata., the fair portal and catalogue will be explained and how a register for a certain disease or product can be set up. Afterwards Novartis will discuss their experience with the procedure.
  •, the fair portal (Hannah Goovaerts,
  • A concrete example (Stefaan Vancayzeele, Novartis)
  • Q&A data
Speakers : Mrs Mrs. Hannah Goovaerts
Project Manager voor de Farmaceutische Projecten - Sciensano
Dr Dr. Stefaan Vancayzeele
Chief Scientific Officer / Medical Director - Novartis
14:15 - 15:10
Hospital Database. Zorgnet-icuro will present their concept of datawarehouses in hospitals' and ZOL will show an example of how researchers can use the data.
  • The Zorgnet-icuro database ( Prof. Tom Balthazar Associate Professor Health Law University Gent/ Legal advisor Zorgnet-Icuro )
  • The ZOL database (Noëlla Pierlet & Dieter Mesotten, ZOL)
  • Q&A
Speakers : Prof. Prof.. Tom Balthazar
Associate Professor Health Law University Gent/ Legal Advisor Zorgnet-Icuro
Mrs Mrs. Noella Pierlet
Clinic Cordinator Data/Information Architect - Ziekenhuis Oost-Limburg
Prof. Dr Prof. Dr. Dieter Mesotten
MD PHD - Ziekenhuis Oost-Limburg
15:10 - 15:25
Coffee break
15:25 - 16:20
Firstline databases. APB will present the data collected by pharmacists: APB, BelPharmData, IFSTAT, TIP from FARMAFLUX and KU Leuven their unique database INTEGO with registration data collected from GPs.
  • Data collected by pharmacists (Wouter Hamelinck, APB)
  • The INTEGO database (Bert Vaes, KU Leuven)
  • Q&A retail databases
Speakers : Mr Mr. Wouter Hamelinck
Hoofd Statistiek Afdeling - APB
Prof Prof. Bert Vaes
KU Leuven
16:20 - 16:30