Subject : Clinical Trials: R&D within the Federal Agency of Medicines and Health Care products in Belgium.

Date: Tuesday May 3, 2011 afternoon session

Venue: De Montil, Essene (Affligem)

Time: 13h45 till 17.30 - we will start on time with a welcome

Mr Kristof Bonnarens and his team will inform us about the activities and several interesting new items for the research and development of the drugs.

13u45 – 14u00: Introduction

14u00 – 15u00 : Clinical trial legislation National versus European:
European:
CTFG activities, Belgium as secretary
Goals, expectations and realisations
IMP vs NIMP

National:
Organisation R&D deptm
Consultation platform: present situation
IMP: present situation - new circular letter
Ph Vig: safety guidances

15u00 – 15u45: GCP inspections - strategy and critical issues
General
Early phase GMP

15u45 – 16u15: coffee break

16u15 – 17u00: Advanced therapies:
Regulatory framework (law of 7 May 2004 - ATMP regulation - Human material law)
Critical issues

17u00 – 17u30: Q&A