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Session Chair(s)
Barbara J Sabourin, FACP
Director General, Health Products and Food Branch
Health Canada, Canada
Learning Objective : Discuss the key challenges of developing and implementing a completely new regulatory framework, and how can they be overcome; Describe how regulatory authorities promote excellence in clinical trials in small populations; Identify tools required to gather patient input and integrate it into regulatory decision making.
Speaker(s)
From Regulation to Implementation: Operationalizing a New Framework for Orphan Drugs
Cathy A. Parker
Health Canada, Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
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