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European Union Filings and Registrations

4/25/2014 10:00 AM - 11:30 AM


This session 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, 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. Product examples will be discussed to illustrate effective filing techniques and when Full vs. Abridged applications will be required. The Course will link the requirements of the EU Clinical Trial Directive and discuss when existing clinical data might be sufficient to file. Related ICH compliant requirements such as GCP and GMP will enter the licensing approval process. Common issues that have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how companies can best address the conflicts that sometimes arise.

Areas Covered in the Session:

How the EU and individual countries within Europe interact

Which registration procedure to use

How regulations effect product development strategies

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 link the strategy of Country selection to an ultimate EU Licensing Plan


EU Agency Regulatory Structure

Registration Options

Company Strategy- Linking Clinical Trials & Marketing Authorization Applications

Balancing Strategy and Regulatory Cost/Maintenance

2007 Pediatric Legislation Overview

IMP Dossier- EU Expectations and Comparison of CTA to IND Applications

Registration Procedures

Mutual Recognition vs. Centralized Procedure

Abridged Applications


Labeling & Packaging Leaflet Requirements

Changes to Marketed Products

Maintaining Your License: Renewals

Decision Making Process

Review of Regulatory Authorities

International, Regional, and Local laws applicable for the European Union

Member State Analysis of Applicable Regulations

Political Implications of the Regulations

Compare/Contrast EMEA and the FDA procedures

How and When to Influence the Regulatory Process

Using Regulations / Regulatory Contacts to Your Advantage

Who Will Benefit:

EU Regulatory

Administrative Staff

Sales or General Management


Clinical Research Organizations

Quick Contact:


USA Phone:800-447-9407

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Learn More: European Union Filings and Registrations

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