MedBridge Global

Introduction of Right to Try Program by Dr. Elliot Lander, MD, FACS.

What is Right to Try Program

Course Agenda

Welcome & Learning Objectives

Module 1: Statutory framework and legislative history

Module 2: Eligibility criteria in depth

Module 3: Right to Try vs. Expanded Access

Module 4: Physician certification, approved options and trial unavailability

Module 5: Informed consent, communication and cellular products

Module 6: Chain of custody and SAE transmission

Module 7: Sponsor annual summary - 21 CFR 300.200

Module 8: Liability, costs, state law and pitfalls

Case Scenario (Assessment, part 1)

Knowledge Check (Assessment, part 2)

What the Research Shows

References

Right to try compliance physician eligibility worksheet

Right to try compliance informed consent template