1. 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

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

3. 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

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

5. Rapid Response to New Requirements
Schering-Plough