Governance and Systems for Drug Safety at Pharmaceutical Companies

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Presentation transcript:

Governance and Systems for Drug Safety at Pharmaceutical Companies Michael Swiatocha SPRI Compliance Officer Schering-Plough Corporation The International Pharmaceutical Compliance Summit Philadelphia, PA March 31, 2004 Schering-Plough

Governance and Systems for Drug Safety Pharmacovigilance Oversight Global QA Model Rapid Response to New Requirements Schering-Plough

Pharmacovigilance Oversight PV is a critical function Global PV organization at S-P chartered to address investigational and marketed products PV Oversight Committee multifunctional membership sets strategic direction for PV at S-P Schering-Plough

Global QA Model Corporate Oversight Audits Regional Assurance Audits Country Level Operations & QC Activity Schering-Plough

Rapid Response to New Requirements Schering-Plough

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