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DIA 2021 Global Annual Meeting
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
- Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison
- GE2P2 Global Foundation, United States

Facilitator
Mariah Sage Gustafson, MA
- Researcher, Grossman School of Medicine
- NYU Langone, United States
Facilitator
Anne Donguy
- Patient Advocate, Sweden