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Non-Trial Preapproval Access to Investigational Medical Products
7:30 AM - 11:59 PM NYU Langone Health
Date: January 13, 2020 to January 13, 2020
Where: NYU Langone Health, 550 1st Avenue , Coles Room #101, New York, New York, United States
Phone: N/A
Event Type: Business
Ticket Price: N/A
"Non-Trial Preapproval Access to Investigational Medical Products: Lessons Learned and Practical Advice Moving Forward" is a one-day conference hosted by the NYU School of Medicine Working Group on Compassionate Use and Preapproval Access (CUPA).  Join us for a discussion of current issues, practical challenges, and controversies surrounding preapproval access to investigational medical products. Speakers will include legal, clinical, industry, and academic experts. There will be time for small-group discussions. A full agenda will be available closer to the date. The conference registration fee is $75 (plus $6.20 Eventbrite handling fee), which includes breakfast, lunch, and coffee breaks.  25 free slots are available for patients, advocates and students. These will be allocated on a first come, first serve basis, and students must provide a copy of their student ID. Please email Jamie Webb at to inquire about these spaces. Registration is non-refundable. Registrations are transferable to another individual if you are unable to attend. Preliminary Agenda 7:30 AM Registration and Breakfast  8:00 AM Welcome and Opening Remarks Alison Bateman-House, PhD, MPH, MA,Co-Chair, CUPA  8:10 AM A Big Picture View of Non-Trial Preapproval Access: What Are We Trying to Do and What are the Risks? Arthur Caplan, PhD, Co-Chair, CUPA (moderator) Jinsy Andrews, MD, MSc, Director of Neuromuscular Clinical Trials, Columbia University  Gregg Gonsalves, PhD, Associate Professor of Law, Yale University, and Co-Director, Global Health Justice Partnership Andrew McFadyen, Executive Director, The Isaac Foundation 9:10 AM The Role of the FDA in Non-Trial Preapproval Access (Expanded Access and Right to Try) Arthur Caplan, PhD, Co-Chair,CUPA (moderator) Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation Christopher Robertson, JD, PhD, Associate Dean for Research and Innovation, Professor of Law, James E. Rogers College of Law, Unive
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