Event Detail
The EU Clinical Trial Directive
September 15, 2009
- Online Not Applicable
BenAstrum Pharma Broad
ardy.heydari@benastrum.com
Phone: (514) 337-1616
Fax: (514) 337-8803
Key Discussion Points will include: -EU Agencies and the Competent Authorities Reporting Structure -Overview of Key Areas of the Clinical Trial Directive -Strategy: Linking Clinical Trial Locations with Marketing Authorization Filings -Implementing Trials Under The EUCTD / Guidance Documents Understanding -Importance of EU GMP and GCP -EU Inspections -Trial Sponsor’s Responsibilities -Roles / SOPs -Comparing & Contrasting FDA IND Process vs. EUCTD