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Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real World Evidence

March 28-29, 2018
  • Washington, DC

CBI’s Expanded Access Programs 2018 focuses on the design, development and practical implementation of early access programs. The summit convenes top industry stakeholders and regulators to examine current approaches in providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes. A multi-stakeholder faculty will address key issues affecting EAPs and review the potential impact of the evolving legislative landscape.

Key Topics to Be Addressed:

  • Share best practices and review comparable processes and
    regulations between U.S. and global expanded access programs
  • Streamline policies and procedures to enable the successful
    launch and sustainability of global EAPs
  • Review industry trends in the collection of real-world data in
    expanded access programs
  • Navigate pricing, payment and reimbursement policy for
    expanded access programs
  • Discuss strategies to integrate EAPs into your drug development
    process at the busiest point of the drug development life cycle
  • Understand the clinician’s perspective on single-patient access
    and group EAPs — Consider barriers to access

Previous Attendee Acclaim:

After ten years in the expanded access space, I learned something new and heard a lot from the patient’s perspective.

Associate Director, Expanded Access, TESARO

Great insights from a variety of perspectives including the patients, regulators and manufacturers, who all addressed real issues.

Vice President, AmericansourceBergen

Definitely, a must-attend.

Director, Global Medical Services, Med Communications

Expanded Access Programs 2018

Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real World Evidence

CBI’s Expanded Access Programs 2018 focuses on the design, development and practical implementation of early access programs. The summit convenes top industry stakeholders and regulators to examine current approaches in providing investigational, pre-launch or end-of-lifecycle drugs to patients for treatment purposes. A multi-stakeholder faculty will address key issues affecting EAPs and review the potential impact of the evolving legislative landscape.

Key Topics to Be Addressed:

  • Share best practices and review comparable processes and
    regulations between U.S. and global expanded access programs
  • Streamline policies and procedures to enable the successful
    launch and sustainability of global EAPs
  • Review industry trends in the collection of real-world data in
    expanded access programs
  • Navigate pricing, payment and reimbursement policy for
    expanded access programs
  • Discuss strategies to integrate EAPs into your drug development
    process at the busiest point of the drug development life cycle
  • Understand the clinician’s perspective on single-patient access
    and group EAPs — Consider barriers to access

Previous Attendee Acclaim:

After ten years in the expanded access space, I learned something new and heard a lot from the patient’s perspective.

Associate Director, Expanded Access, TESARO

Great insights from a variety of perspectives including the patients, regulators and manufacturers, who all addressed real issues.

Vice President, AmericansourceBergen

Definitely, a must-attend.

Director, Global Medical Services, Med Communications