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Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.
Learning Objective : Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.
Speaker(s)
Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc
Rubix Health LLC, United States
Founder and Strategic Advisor, CTMP; Founder
Patient Perspective
Julie Eller
Arthritis Foundation, United States
Patient and Manager of Grassroots Advocacy
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