Governance and Systems for Drug Safety at Pharmaceutical Companies

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
2
Governance and Systems for Drug Safety

1. Pharmacovigilance Oversight
2. Global QA Model
3. Rapid Response to New Requirements

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

4
Global QA Model
Corporate Oversight Audits
Regional Assurance Audits
Country Level Operations QC Activity
5
Rapid Response to New Requirements