Thursday 24 September 2009 - 13:30 until 17:30

Language: English

Location: De Montil, Essene (Affligem)

The speakers will be Mr. K. Bonnarens and several of his colleagues for the R&D Department part and Prof. M. Bogaert for the Ethic committees part.

The agenda will be completed, but topics that will be treated are:

• EC directive on clinical trials
o Recent developments at EU level (CTFG – Ad Hoc Group)
o The R&D division in the Directorate-general Pre-Authorisation
o Projects ongoing
• Early phase development
o Note for guidance
o Experiences so far
o GMP/GCP issues
• Ethics Committees in Belgium
o Non-interventional clinical trials
o Interactive website

• GMP – GCP
o Current status
o GCP + implementation

If you have any questions or suggestions for the agenda, please let us know before 01/09/2009, we will take your suggestions into account.

Mailing to follow.