The EU Clinical Trial Regulation – EU Filings & Registrations

Strategies for streamlining the registration application process for faster approval.

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].

This course also 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.

Attendees will leave the Course clearly understanding the requirements under the current Regulations. 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
  • 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 registration pathway
  • How to stay compliant What can make the difference in your data passing Regulatory scrutiny
  • Related area-GCP and PV-reporting updates
  • Impending Changes of the EU Clinical Trial Regulation and timing for Implementation

Who will get the 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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Author: GlobalCompliancePanel-Training

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

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