The data supporting pharmaceutical regulatory compliance is usually present but rarely assembled into a decision. Accreditation bodies assess this part of health and pharmaceutical services on documented evidence of consistent practice. It suits anyone whose decisions touch this area of health and pharmaceutical services, in large organisations and small ones alike. The programme is built to be used, and every section of pharmaceutical regulatory compliance it covers ends in something applicable. Participants develop a defensible line of reasoning for the choices they make about this strand of health and pharmaceutical services. Ambition around this part of health and pharmaceutical services outruns capacity unless the sequencing is deliberate. Mature organisations treat pharmaceutical regulatory compliance as a standing capability rather than a project that finishes. Exercises escalate in difficulty, ending with the ambiguous situations that make the practice within health and pharmaceutical services hard in practice. The final module sets out how progress on this area of health and pharmaceutical services will be evidenced six months later.
Expected Learning Outcomes
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Audit pharmaceutical regulatory compliance in practice, not only in policy.
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Apply a repeatable review cycle to pharmaceutical regulatory compliance and act on what it produces.
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Prepare a short, evidence-based briefing on pharmaceutical regulatory compliance for senior management.
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Apply root cause analysis to adverse events involving pharmaceutical regulatory compliance.
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Plan staffing and rota cover appropriate to demand in pharmaceutical regulatory compliance.
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Manage the supply chain and cold chain supporting pharmaceutical regulatory compliance.
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Build the internal capability for pharmaceutical regulatory compliance rather than depending on external support indefinitely.
Who Should Attend
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Health information and records staff supporting pharmaceutical regulatory compliance.
