The European Clinical Trial Directive Plus European Filings and Registration Procedures 2015 is a seminar that covers topics such as:
- 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
The European Clinical Trial Directive Plus European Filings and Registration Procedures 2015 brings together:
- Project Team Members
- Clinical Operations Staff
- Regulatory Affairs Personnel
- Quality Assurance, Monitors, CRAs
- Clinical Trial Supply
- Investigators & Site Study Staff
- CROs, Consultants, Insurers
