Definition

A cross-functional committee responsible for reviewing safety data, making risk management decisions, and overseeing the company's pharmacovigilance activities.

Example

The monthly DSC meeting reviews new signals, aggregate safety data, ongoing studies, and makes decisions about labeling changes, REMS modifications, or study protocol amendments.

Regulatory source

Company Governance, ICH E2E

Common mistakes

Having DSC meetings without clear decision-making authority or without appropriate cross-functional representation.

Inspector question

Describe your DSC composition and charter. How are decisions documented and implemented?

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