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Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets?
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
This session will evaluate approval approaches to see how these could best be harnessed across agencies to provide new pathways for accelerated patient access to medicines. It will also provide an overview of approval pathways and perspectives on the global opportunities and hurdles.
Learning Objective : Categorize the different routes of approval that are currently being used or suggested by both mature and emerging agencies; Illustrate the advantages and hurdles of different approaches for licensing authority, health technology assessment, and companies; Discuss the opportunities for global medicine development and patient access.
Speaker(s)
Adaptive Licensing: An Update on International Developments
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Towards An Adaptively Learning Regulatory System: Current Challenges From a Regulatory Science Perspective
Pieter Stolk, PharmD, PhD
University Medical Centre Utrecht, Netherlands
Project Manager
Novel Development and Licensing Models: The Experience from Taiwan
Gau Churn-Shiouh, DrSc
Project Office of Sustainable Platform For Big Data In Health By MOHW, Ching-Kan, Taiwan
Office Director
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