Conference:
'The European Directive 2001/20/EC, 6 years on'

We have had 6 years to work out how to implement the European Directive 2001/20/EC regulating Clinical Trials.

We now know what actually works/could work and what does not work. Speakers from all over Europe were invited to explain how to set up trials in their specific countries so that we can find out different ways of interpreting the Directive.

Why you should attend

1. Most issues you are struggling with, while setting up your trials will be addressed:

• Ethics
• GMP compliance
• Sponsorship
• Pharmacovigilance
• Indemnity
• Agreements
• Monitoring/inspecting

2. All countries have interpreted the Directive differently, you might work out the simplest ways of being compliant.

3. DG III of the European Commission envisaged a review of the Clinical Trials Directive achievements in 2009. Now is our chance to emphasise what is not working and propose changes.

Who should attend?

Anybody involved in the setting up / conducting / monitoring / auditing / inspecting of Clinical Trials.

Last updated 17 September 2007