The EU Clinical Trial Regulation - EU Filings & Registrations

  • 545.00 Dollar US$
  • Published date: July 3, 2019
    • Fremont, California, United States

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers 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].

Who Will Benefit
Business Management
Project Team Members
Legal Team Members
Clinical Operations Staff
Quality Assurance, Monitors, CRAs
Regulatory Affairs
Investigators & Site Study Staff
CROs, Consultants, Insurers

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John Robinson
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