The language for the symposium is English.

09.00 REGISTRATION & COFFEE

09.30 Welcome Address
Pieter De Pourcq, BRAS President

09.45 New Structure - Objectives - Realisations
Challenges for 2009
Greet Musch, Vanessa Binamé

10.45 Domain of Excellence (pro-active vigilance)
Thierry Roisin

11.15 COFFEE BREAK

11.30 Domains of Excellence at the FAMHP: Early Phase Development, Vaccines, and Oncology
Sonja Beken

12.00 Changes to Module 1, Application Form, Special points of attention, Errors
Sofie Colyn, Katelijne Van Keymeulen

12.30 Questions & Answers

12.45 LUNCH

13.45 e-Submissions: future ?
Pieter Vankeerberghen, Anne Verhoye

14.05 Variations Regulation
Iris Geussens

14.50 Experience PIL user testing / Harmonisation (Risk analysis - Bridging - Clarifications)
Bruno De Schuiteneer

15.20 COFFEE BREAK

15.50 PSUR Worksharing Sophie Goethals

16.20 Scientific Advice
Greet Musch, Christophe Lahorte

16.50 Questions & Answers

17.15 Closing Remarks
Pieter De Pourcq

17.30 COCKTAIL