2014 - European Union Filings and Registrations

Overview:
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
Agenda
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
Variations
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
Compliance
Clinical Research Organizations
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1gZwEae