Pharmaceutical Filings & Registration Procedures in the EU - Webinar By GlobalCompliancePanel 2012

Key Topics

• Registration Options
• EU Agency Regulatory Structure
• Balancing Strategy and Regulatory Cost/Maintenance
• Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
• IMP Dossier- EU Expectations and Comparison of CTA to IND Applications
• Pediatric Legislation Overview
• Mutual Recognition vs. Centralized Procedure
• Registration Procedures
• Variations
• Abridged Applications
• Changes to Marketed Products
• Labeling & Packaging Leaflet Requirements
• Decision Making Process
• Maintaining Your License: Renewals
• International, Regional, and Local laws applicable for the European Union
• Review of Regulatory Authorities
• Political Implications of the Regulations
• Member State Analysis of Applicable Regulations
• How and When to Influence the Regulatory Process
• Compare/Contrast EMEA and the FDA procedures
• Using Regulations / Regulatory Contacts to Your Advantage

Who should Attend

Administrative staff, Regulatory personnel, Sales or general management, Compliance Professionals and Clinical Research Professionals.