Market Access - Workshop on Art. 81

BRAS Workshop on Art. 81 agreements with the authorities

Novotel Brussels Airport, June 19th 2014

The session is organized for persons involved in Regulatory Affairs, Market Access and Pricing and Reimbursement of medicines.
Managed Entry Agreements (MEA) are used all over Europe by the national health care payers to manage aspects of uncertainty associated with the introduction of new medicinal products. In Belgium there is the possibility to negotiate MEAs for Class I pharmaceutical products, orphan drugs or extensions of indication under specific conditions. This year, and based on the experience of the past, the modalities of the “Art. 81 agreements” where reviewed and adapted.
A panel of experts from University and RIZIV/INAMI will guide you on an interactive way through the various aspects of the adapted regulations. Participants will also acquire relevant guidance and practical experience on how to address the different approaches to specific situations in the management of Art. 81 agreements.
A panel discussion with representatives of the FPS Social Security, RIZIV/INAMI and sick funds will end the session.
Participants will, prior to the course day, also have the opportunity to submit their general questions or specific cases which we will submit to the experts for discussion during the panel session.
This one day BRAS workshop will take place on Thursday 19 June 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 Introduction
Lies Delmulle & Inneke Van de Vijver, BRAS Market Access Work Group

10h10 Art 81 – Legal update
Procedure – Workgroup Art. 81 – Remaining questions
Francis Arickx, RIZIV/INAMI – Ellen Vanhaeren, RIZIV/INAMI

11h20 Coffee break

11h50 Practical aspects of regulation.
Facts & figures – strategic options – be prepared – the day after
Francis Arickx, RIZIV/INAMI – Ellen Vanhaeren, RIZIV/INAMI

12h30 How to handle clinical uncertainty in Art. 81 agreements
Katelijne De Nys, KU Leuven – Chair CTG/CRM

13h00 Lunch

14h00 Art. 81, perspective of the workgroup
François Sumkay, LCM / UNMC

14h30 Panel discussion

Moderator: Peter Backx

K. De Nys, KU Leuven;
A. Kupperberg, Expert FPS Social Security;
F. Sumkay, LCM/UNMC;
E. Vanhaeren, RIZIV/INAMI

15h30 Questions & answers

16h00 End of the session

Registration via BRAS website: or contact for assistance.

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

Cancellation : Cancellations will neither be accepted nor reimbursed after 10 June 2014. Before that date 20% will be retained for administrative costs.

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