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

  • 22 Aug 2012
  • Webinar

Description

Pharmaceutical Filings & Registration Procedures in the EU is a webinar that covers topics such as:

  • 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

Pharmaceutical Filings & Registration Procedures in the EU brings together Administrative staff, Regulatory personnel, Sales or general management, Compliance Professionals and Clinical Research Professionals.

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Important

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Event Categories

Health & Medicine: Pharma

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