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2022 ISPE Annual Meeting & Expo

SES109a - Risk Assessment for Drug Availability


Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


Description

Recently, multiple health authorities including the US FDA have instituted requirements for risk assessment related to drug availability for patients. These concepts additionally are being incorporated into the revision of ICH Q9 on Risk Assessment which could further increase the regulatory expectations. This presentation will discuss an approach for a holistic end to end evaluation of product supply risks and provide mitigation strategies that go beyond supplier redundancy and stockpiling.

Speaker(s):

  • Christine Moore, PhD, Executive Director, Quality Systems & Compliance, Organon LLC

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