BRAS Workshop on Biopharmaceuticals

BRAS Workshop on Biopharmaceuticals 

 Actual and future challenges 

Novotel Brussels Airport, 2 April 2015


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

A panel of experts, representing the different stakeholders, will give their view on the current regulatory, scientific and market access perspectives for biopharmaceuticals.

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 2 April 2015 at the Novotel Brussels Airport, 1831 Diegem, from 09h30 to 16h45.

The language for the workshop is English.

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:

09h00   Registration and coffee

09h30   Welcome & introduction to the course
            Inneke Van de Vijver, BRAS Market Access Working Group

09h45   Introduction to biotechnology

            Annie Hubert, ESAH Bio pharma Consulting

10h30   Assessing biopharmaceutical uptake and competition in European markets

Patrick Van Dooren, Engagement Manager, Technology and Services IMS Health


11h15   Coffee break


11h40   General state of the art – Extrapolation of indications, the rationale? – Interchangeability / switch while on treatment, acceptable or not?

Karen De Smet, Non-Clinical Assessor FAMHP, member of the BMWP and expert in the SWP and VWP at EMA


12h30  Post marketing obligations. Safety & efficacy data collection in registries: one for all?

            Laurence de Fays, Pharmacovigilance Assessor FAMHP


12h50   Future landscape of biopharmaceuticals, vision of FAMHP

            Christophe Lahorte, Directorate-General Pre-Authorisation, Head of Scientific-Technical Advice & KM Unit -  FAMHP


13h00   Lunch


14h00   Physicians perspective

            René Westhovens, MD PhD Rheumatologist KU Leuven


14h45 Pharmacists perspective.

            Jo Swartenbroekx, Director Pharmacy and Logistics UZ Antwerp


15h15 Coffee break


15h45 Vision of the “originators” industry organization

            Bart De Greef, Expert Healthcare Biotechnology and SME -


16h15 Vision of the “biosimilars” industry organization

            Johan Eykens, Director Health policy Febelgen


16h45   End of the session

Registration via BRAS website: or contact for assistance.

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