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Navigating Non-Trial Preapproval Access as a Patient
Session Chair(s)
Alison Bateman-House, PHD, MA, MPH
Assistant Professor, Division of Medical Ethics, Dept of Population Health
NYU Grossman School of Medicine, United States
In this interactive live session, we will cover the patient experience in recieving non-trial preapproval access. This panel discussion features experts in industry, FDA policy, ethicists, and patient advocacy.
Learning Objective : Identify the overlapping roles of industry and government with regard to non-trial preapproval access to investigational medical products; Describe and apply the process through which patients go to receive non-trial preapproval access; Recognize policies on Expanded Access and Right to Try from the perspective of patients/patient advocates.
Speaker(s)
Facilitator
Richard Klein
GE2P2 Global Foundation, United States
Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison
Facilitator
Mariah Sage Gustafson, MA
NYU Langone, United States
Researcher, Grossman School of Medicine
Facilitator
Anne Donguy
Patient Advocate, Sweden