Registration Procedures

• Member State Procedures
• Mutual Recognition Procedure
• Centralized Procedure

Abridged Applications

• Similar Products & Devices
• Non-t "Similar" Products & Devices
• Request for Extensions
• Use of Expert Reports

Variations

• Changes Concerning Manufacturing Aspects (Product & Process)
• Labeling & Packaging Leaflet Requirements
• EU Commission Regulations
• Mutual Recognition Procedure
• Centralized Procedure

Decision Making Process

• Scope
• Check-in Procedure
• Internal Commission
• Consultation
• Industry's Ability to Impact
  - Involvement & Timing
• Standing Committee Participation
• Favorable Standing Committee Opinion
• Non-Favorable Opinion
  - Process & Timing

Review of Regulatory Authorities

• International, Regional, and Local laws applicable for each European Union Nation

Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are Applied

• Legislative Process
• Objectives of the Rules Governing Medicinal Procedures
• Regulatory Framework
• New Products, Requirements, & Procedures

Political Implications of The Regulations

• Compare/Contrast EMEA and the FDA procedures

How and When to Influence the Regulatory Process

• Effective Monitoring Activity
• Association vs. Individual Company Involvement & Intervention
• The Regulatory Negotiation Process
• Effective Approaches
• The Do's and Don'ts of Regulatory Involvement

How to Use Regulations / Regulatory Contacts to Your Advantage

• Check-in Procedure
• Internal Commission Interactions
• Procedures within each regulatory office, contacts, etc.
  • Product Development Strategy
• Business Impact Within and Outside the EU
• Professionalism in Regulatory Lobbying

Changes to Marketed Products

Case Study - A Review of the Filing/Registration Procedure


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