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USP/IQ Consortium Roundtable: Characterization strategies of Subvisible Silicon Oil Droplets

October 7, 2024 - October 7, 2024

Roundtable

Location: Hybrid

Venue: USP Headquarters, Rockville, MD

Register for this Event

Monday, October 7, 2024 | 8:00 a.m.–4:00 p.m., US ET
USP Headquarters, 12601 Twinbrook Parkway, Rockville, MD 20852

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Overview:

This free hybrid event will convene experts from industry, regulatory bodies, and academia to explore the implications of subvisible silicone oil droplets on particle analysis, drug product safety, and process control. The discussion will focus on potential clinical risks posed to patients by these "silicone particles" and how analytical methodologies can be used to distinguish these particles from others.

Why Attend:

The round table is a joint-collaboration of USP Dosage Forms Expert Committee & the IQ Consortium that will facilitate an exchange of knowledge and strategies among stakeholders. Engage with experts from FDA’s CDER, IQ Consortium, and USP on subvisible silicone oil droplets, particle analysis, drug product safety, and process control to better understand and manage silicone particle-related challenges in pharmaceuticals.

Who Should Participate:

Reference Articles:


For further information or to suggest additional stakeholder topics related to USP General Chapters, contact them at gc@usp.org.