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Combination Products
Session Chair(s)
Khaudeja Bano, DrMed, MD, MS
Vice President, Combination Product Quality
Amgen, United States
A workshop to explore the world of combination product safety. Discuss the real-world, least burdensome approach to Postmarket Safety Reporting (PMSR) for US Combination Products, in light of the final rule. Help the audience appreciate the complexity of implementing PMSR in a global organization. Participants will work in teams to work through mock case(s) of combination products approved as drug application type with a device constituent part. We will have interactive discussion about key challenges including global impact and highlight industry best practices.
Learning Objective : Describe the basic requirements as highlighted in the final rule; Identify simple solutions to comply with the regulation.
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