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Impact of Accelerated Pathways on Patients in Five Countries/Regions
Session Chair(s)
Sunita Zalani, PhD
Vice President, Regulatory Affairs, Oncology
Merck & Co., Inc., United States
Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.
Learning Objective : Recognize the differences of accelerated pathways in US, EU, Canada, Japan and Australia; Discuss the impact of these pathways on patient access and treatment outcomes; Identify opportunities to increase global collaboration and international patient equity.
Speaker(s)
EMA Update
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
Health Canada Update
Isabelle Rousse, MSc
Health Canada, Canada
Associate Director, Bureau of Metabolism, Oncology, Reproductive Sciences, PDD
PMDA Update
Yoko Aoi, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug V
FDA Update
R. Angelo De Claro, MD
FDA, United States
Associate Director for Global Clinical Sciences, Oncology Center of Excellence
Industry Update
Kathleen Winson, MPH, MS
Genentech, A Member of the Roche Group, United States
Executive Group Director, Product Development Regulatory
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