Harmonisation Beyond the Implementation of the Clinical Trial Directive

Venue: Scandic Hotel

Location: Copenhagen, Denmark

Event Date/Time: Sep 28, 2006 End Date/Time: Sep 29, 2006
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Description

Key Issues to be Presented:
•Pharmacovigilance Aspects
•The Investigational Medicinal Product Dossier (IMPD)
and Clinical Trials Authorisation (CTA) Applications
to Competent Authorities
•Impact of the Clinical Trials Directive on
Ethics Committees in Europe
•GMP Issues
•Compliance and Monitoring
•Compliance and Inspections
•Electronic Data Capture (EDC)
•Eudravigilance, EudraCT and Eudravigilance
Medicinal Products Dictionary and the Eudra Data Warehouse.

Venue

6 Vester Sogade
Copenhagen
Denmark
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