The EU Clinical Trial Regulation + EU Filings & Registrations 2017

  • 1695.00 Dollar US$
  • Published date: September 21, 2017
    • Zurich, Switzerland, Hilton Zurich Airport, United States

Course "The EU Clinical Trial Regulation + EU Filings & Registrations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Learning Objectives / Key Topics:

Attendees will leave the Course clearly understanding the requirements under the current Directive. In addition, this Course has been updated to provide participants with competitive insight into:
• How the EU and individual countries within Europe interact
• Which registration procedure to use
• How regulations effect product development strategies
• Pricing issues - Coordinated filing vs. Individual filing
• Understanding the concerns/issues of European Regulatory Personnel
• How to negotiate with the regulators
• Information necessary for effective submissions
• Strategies for streamlining the registration application process for faster approval
• The advantages and disadvantages of various registration procedures
• How to efficiently initiate trials.....first patient, first visit
• How to link the strategy of Country Selection to an ultimate EU Licensing Plan
• Efficiently implementing studies via project teams and CROs at the National and multi-state level
• How to stay compliant.....What can make the difference in your data passing Regulatory scrutiny
• Related area-GCP and PV-reporting updates
• EUCTD and EUCTR vs. FDA IND Regulations
• Impending Changes of the EU Clinical Trial Regulation and timing for Implementation


Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

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