The EU Clinical Trial Regulation + EU Filings & Registrations 2017

  • 02-03 Nov 2017
  • Hilton Zurich Airport, Switzerland

Description

The EU Clinical Trial Regulation + EU Filings & Registrations 2017 is a conference 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
  • Impending Changes of the EU Clinical Trial Regulation and timing for Implementation
  • EUCTD and EUCTR vs. FDA IND Regulations

Past Events

Important

Please, check "The EU Clinical Trial Regulation + EU Filings & Registrations" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Dentistry, Medical technology

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