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Recent Experiences with Adaptive Licensing and Facilitated Regulatory Pathways
Session Chair(s)
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Facilitated regulatory pathways (FRPs) and transformative adaptive licensing (AL) procedures can accelerate patient access to medicines. This forum will review recent experiences, facilitators and how barriers have been overcome for effective use of FRPs and considerations for AL pilots.
Learning Objective : Discuss perspectives of stakeholders to the barriers and opportunities to using adaptive licensing (AL) or facilitated regulatory pathways (FRPs); Identify the characteristics that may contribute to a successful AL or FRP process; Describe results of the use of AL and FRP models in various jurisdictions.
Speaker(s)
Stakeholder Perceptions of Adaptive Licensing and Facilitated Regulatory Pathways (FRPs)
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Marketing Authorizations for Earlier Patient Access: Regulatory Challenges in Japan
Daisaku Sato, PhD, MPharm, RPh
ex-Councilor for Pharmaceutical Affairs, Ministry of Health, Labour and Welfare, Japan
Bringing Innovative Medicines to Patients and Maximizing Benefits to Public Health Through Adaptive Licensing
Hans-Georg Eichler, MD, MSc
Consulting Physician, Austrian Association of Social Security Bodies, Austria
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