What should a sponsor do when the USFDA disagrees? This presentation will include an analysis of data extracted from milestone meeting minutes related to interactions between applicants and the FDA for approvals under the Center for Drug Evaluation and Research (CDER). The data is used to classify and categorize the interactions to facilitate continuous improvement and increased awareness of the FDA’s approach and current thinking.
This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.
Learning Level: Basic
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
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About Your Presenter:
Amin Osmani, is the co-founder and CEO of Biotech Square. He spent the last 10 years supporting the business development of pharmaceutical companies and contract research organization at various stages of the drug development process. He became passionate about addressing process delays that add significant development costs and make medical innovation less sustainable. He founded Biotech Square to uncover insights drug development teams can learn from to avoid delays and failures. Amin is a McGill University B.Sc. graduate in Biology and a Concordia University M.Sc. graduate in Cell & Molecular Biology.
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