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Harmonisation Beyond the Implementation of the Clinical Trial Directive

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Event Harmonisation Beyond the Implementation of the Clinical Trial Directive
Begins September 28, 2006
Ends September 29, 2006
Papers
Ab.
Country Denmark
State
City Copenhagen
Email dia@diahome.org
Category Health
Category 2 -
Category 3 -
Exhibits N
Organization
Contact 800 Enterprise Road, Suite 200 Horsham, Pennsylvania
URL
Venue Scandic Hotel
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.
Additional Information



 

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