CBI’s Premier Forum on Pre-Approval Access Programs provides the first meeting to network and review case studies, panel discussions and presentations on Expanded Access Programs and Named Patient Programs for the Bio/Pharmaceutical Industry. Attendees will have the opportunity to hear innovative programs that provide early distribution of their products for enhanced patient care and market access. Topics to be discussed include:
• Optimize Early Patient Access
• Communicate the Value of Pre-Approval Access Programs to Internal Stakeholders
• A Cost Benefit Analysis for Named Patient Programs
• The Regulations for Expanded Access Programs
• Gaining Government Support for Named Patient Programs in Multiple Foreign Markets
• Internal Development for Compliant Documentation and Program Management
• Understanding Successful Implementation Procedures for Pre-Approval Access Programs
• Reviewing Best Practices for Monitoring and Reporting Product Safety Data
• Gathering Valuable Patient Data for Pre-Approved Products