6th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs

A tailored, two-day meeting for those considering or currently working on the design and execution of a variety of access management programs, including but not limited to: Expanded Access Programs, Early Access Programs, Compassionate Use Programs, Named Patient Programs and Managed Access Programs.

Share best practices and lessons learned around providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes. 
 

A Comprehensive, Two Day Program On:

• The impact of health reform and the FDA Amended Rule on expanded access
• Program design elements, protocol recommendations and resource needs
• Critical decisions around program launches and lifecycle management
• The compliant use of pre-approval communication strategies to publicize a program
• The execution and management of U.S. and global programs
• Strategies to transition clinical trial subjects to EAPs and then to commercially available products
• The patient advocacy perspective on building relationships with physicians and patients
• The patient perspective on program enrollment and assistance

Mixed Formatting Designed to Enhance Your Conference Experience, Including:

• Q&A with the FDA
• Patient Advocacy Panel
• Patient Spotlight Roundtable Discussion
• U.S. and Global Case Studies
• Breakout Discussion Groups Based on Region

PLUS! Network with attendees from our co-located event – CBI’s Orphan Drug Innovation Summit 2013