PTI - international

Agenda: Day Two

V. Examine the Mutual Recognition Procedure (MRP) and the New Decentralized Procedure

• Determine when and why to use both procedures
• Select a Reference Member State
• Explore submission document content
• Address regulatory planning from submission in Reference Member State to approval
• Discuss regulatory planning after approval in Reference Member State
• Analyze procedural differences between European member states
• Examine the role of the Co-ordination Group CMD (previous Mutual Recognition Facilitation Group, MRFD)
• Analyze arbitration procedures

Exercise: Analyze Product Examples and Decide Whether to Use the Centralized or Mutual Recognition Procedure

VI. Describe Post-Approval Procedures

• Examine the submission process for product variations and renewals in both the Centralized and Mutal Recognition procedures
• Define abridged and bibliographical application procedures and dossier content
• Analyze pricing and reimburesement processes
• Conduct Phase IV clinical trials
• Identify referral procedures

VII. Analyze Specific Product Challenges

• Outline criteria for Orphan drug applications
• Clarify requirements for products of animal origin and discuss implications of the TSE guidelines
• Explore regulations surrounding biologics and Genetically Modified Organisms (GMOs)

VIII. Handle the Regulatory Repercussions of European Union Enlargement and Prepare for Future Regulatory Changes

• Discuss the effects of the addition of 10+ member states
• Anticipate future shifts in EU approval regulation
• Examine the impact of the International Council on Harmonization
• Outline prospective scenarious to 2010

Exercise: Examine Ways to Ensure Your Company is Prepared for Future European Regulatory Changes