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.
