2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements

This European Regulatory webinar is designed to provide an overview on the changes to the variation rules, classifications and filing requirements for all active pharmaceutical, biologics and orphan drug licenses in the EU.

Areas Covered in the Seminar:

• The European Regulatory Structure.
• How the Commission and Individual Member States within Europe interact.
• New Rule Changes for Type IA, IB and Type II Variations.
• New Variation Application Submittal Form.
• New Variation Guidance Document, including conditions to be met and necessary appended documents per the rule.
• New Processing Times for EU variations.
• New Bundling Rules & Fee Payments for EU Variation Submittals.
• License Holders Responsibilities.
• Understanding the Concerns/Issues of European Regulatory Personnel.
• How to Negotiate with the Regulatory Agencies.