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
Past Events
The European Clinical Trial Directive…Plus…European Filings and Registration Procedures 2015 - 25-26 Jun 2015, Tampa, Florida, United States (48782)
Important
Please, check "The European Clinical Trial Directive…Plus…European Filings and Registration Procedures" official website for possible changes, before making any traveling arrangements
