BRAS European symposium 2013 will take place on Thursday 14 November 2013.

Location : Sheraton Rogier, 1000 Brussels

Fees : 575€ for the BRAS members & 765€ for non members
Cancellation :
Cancellations will neither be accepted nor reimbursed after 31 October 2013.   Before that date 20% will be retained for administrative costs.

PROGRAMME

08.30 REGISTRATION & COFFEE

09.30 Welcome Address
Kuo-Wei Chan, BRAS President

09.40 Setting the scene, latest developments at EU level
Noël Wathion

10.00 The new business plan of the FAMHP: highlights
Xavier De Cuyper

I. Scientific Advice

10.20 National Scientific-Technical Advice
Christophe Lahorte

10.40 The work of the SAWP and experiences with joint EMA and HTA advice
Minne Casteels

11.00 COFFEE BREAK

11.40 Parallel EMA and FDA advice
Hilde Boone

12.00 Q&A

12.30 LUNCH

II. Experiences with the new Pharmacovigilance Legislation since its
implementation

13.30 Experiences from the PRAC
Jean-Michel Dogné

13.50 An Industry perspective
Geert Preuveneers

14.10 Impact on the role of the CMDh
Sophie Colyn

14.30 Q&A

15.00 COFFEE BREAK

III. Topics of special interest

15.30 Globalisation:
International and European collaboration
Experiences from EMA-FDA and liaison placements
Hilde Boone

15.50 Benefit-risk throughout the lifecycle of a drug: State of the art and implementation of the new Medicines Commission for drugs for human use
Greet Musch

16.10 Biosimilars
Karen De Smet

16.30 Shortage of Drugs
Els Geeraerts / Vivien Moffat

17.00 Closing remarks
Kuo-Wei Chan, BRAS President

17.10 COCKTAIL

Speakers

Hilde Boone, EMA, EU Institutional Liaison Officer
Minne Casteels, Professor at KU Leuven (Department Pharmaceutical and Pharmacological Sciences), Member of Scientific Advice Working Party (SAWP)
Sophie Colyn, FAMHP, CMDh representative for Belgium & Head of division AMM, DGPRE Authorization
Karen De Smet, FAMHP, Non-clinical Assessor, DGPRE Authorization
Xavier De Cuyper, FAMHP, Chief Executive Officer
Jean-Michel Dogné, Professor at University of Namur - FUNDP & FAMHP representative at PRAC
Els Geeraerts, FAMHP, Coordinator International Relations, Services of the CEO
Christophe Lahorte, FAMHP, Coordinator of the Unit for Scientific-Regulatory Advice & Knowledge Management Unit, DGPRE Authorization
Vivien Moffat, Amgen Europe, International Quality, External Affairs
Greet Musch, FAMHP, Director General PRE-Authorisation
Geert Peuveneers, MSD, Executive Director, Regulatory Affairs Europe
Noël Wathion, EMA, Chief Policy Adviser

Panel moderators
Siska De Moor, BRAS Education Group
Ingrid Theeuwes, BRAS Education Group

Cancellation :
Cancellations will neither be accepted nor reimbursed after 31 October 2013. Before that date 20% will be retained for administrative costs.