BRAS Workshop on Registries, observational studies and the challenges of data gathering for drug reimbursement purposes

Novotel Brussels Airport, December 4^th 2014

The session is organized for persons involved in Regulatory Affairs, Market Access / Pricing and Reimbursement.

The course is intended to provide a basic knowledge and understanding of the main principles and key dynamics related with the use of registries and observational studies in a Belgian context.

There is an ever increasing demand for gathering (real life) data within the scope of drug reimbursement. Registries and observational studies need to be set up; which leads to an increased complexity and has a considerable impact on all parties (companies, physicians, government & payers) involved.

A panel of experts will guide you on an interactive way through the various practical aspects of the set-up. The actual and future developments on the proper use of registries and observational studies will be highlighted and help you to gain insight into the different stakeholders view.

Participants will, prior to the course day, have the opportunity to submit their general questions or specific cases which we will submit to the experts for potential integration in their lecture.

This one day BRAS workshop will take place on Thursday 4  December 2014 at the Novotel Brussels Airport, 1831 Diegem, from 10h00 to 16h00.

The language for the workshop is Dutch and French.

The course is open to anyone interesting in learning, but in order to grant the participants the best teaching quality, the attendance is limited. Therefore, if you are interested in following the course, early registration is recommended.

Programme and Speakers:

09h30    Registration and coffee

10h00    Welcome & introduction to the course
                Anne Bruneel & Leen De Paepe, BRAS Market Access Working Group 

10h15    Real world data in the Belgian Pharmaceutical reimbursement setting
                Vera Bormans & Philippe Van Wilder, SMART & BI, Access to Health Care  

11h00    Coffee break

11h30    Healthdata.be: Harmonization of data collection and management of Belgian research registries public health and health care.

                Johan Van Bussel, WIV-ISP Healthdata.be, Head of Service

12h15    Data gathering: the perspective of a clinical scientist

                René Westhovens, MD PhD Rheumatologist KU Leuven

13h00 Lunch

14h00    Data gathering: the objectives and mission of IMA-AIM. A practical approach

                Joeri Guillaume, Program Manager IMA-AIM; Senior medewerker studiedienst  Nationaal Verbond van Socialistische Mutualiteiten (NVSM)

15h00    Coffee break

15h30    Real world evidence (RWE) in market access: European perspective

                Philippe Van Wilder, VUB, Dept. of Clin. Pharmacology and Pharmacotherapy

16h30    End of the session

Registration via BRAS website:  www.bras-org.be or contact bras@bras-org.be for assistance.

Fees: 450€ for BRAS members - 550€ for non-BRAS members