The European Clinical Trial Directive…Plus…European Filings and Registration Procedures 2015

Key Topics

• Which registration procedure to use
• How the EU and individual countries within Europe interact
• Pricing issues – Coordinated filing vs. Individual filing
• How regulations effect product development strategies
• How to negotiate with the regulators
• Understanding the concerns/issues of European Regulatory Personnel
• Strategies for streamlining the registration application process for faster approval
• Information necessary for effective submissions
• How to efficiently initiate trials…..first patient, first visit
• The advantages and disadvantages of various registration procedures
• Efficiently implementing studies via project teams and CROs at the National and multi-state level
• How to link the strategy of Country Selection to an ultimate EU Licensing Plan
• Related area-GCP and PV-reporting updates
• How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny
• EUCTD vs. FDA Regulations

Who should Attend

• Project Team Members
• Clinical Operations Staff
• Regulatory Affairs Personnel
• Quality Assurance, Monitors, CRAs
• Clinical Trial Supply
• Investigators & Site Study Staff
• CROs, Consultants, Insurers