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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 For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1dl9zCh
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