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