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| Begins |
September 28, 2006
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| Contact |
800 Enterprise Road, Suite 200
Horsham, Pennsylvania
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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.
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