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Case Studies

BACKGROUND

• Project and Validation Management for Global Pharmacovigilance and Clinical Safety System
• Solution roll out in the US, Europe and Japan
• Short implementation window
• Historically different ways of working across regions

OBJECTIVES

• Sourcing a cost effective, fit for purpose supplier and solution
• Harmonisation of PV processes across regions and organisations
• Compliance with global regulations and E2B requirements
• Harmonise and optimise computer system validation to minimise additional effort at sites

ROLE

• Establish global project team structure, steering committee, core central team, regional coordinators and implementation teams
• Requirements Definition, Programme, Risk, Cost and Resource Management
• Validation integrated with supplier approach, leverage supplier effort and documentation where possible
• Maintain communication with authorities for E2B testing
• Manage global validation team

OUTCOMES

• Harmonised global PV processes
• Validated solution across regions
• Project delivery to time and budget

CHALLENGES

• Data Migration from multiple and varied existing PV systems
• Different working practices and cultures across regions
• Go live planning synchronised to regulatory reporting deadlines
• Gaining buy in to change and system ownership accountabilities

BENEFITS

• Effective sharing and reporting of safety data across regions
• Resource mobility across regions due to harmonised processes
• Compliant with current E2B reporting requirements
• Lower global system management costs
• Successful regulatory inspection
• Effective sharing and reporting of safety data across regions