Extending Governance to the local level
To obtain and maintain a holistic view of patient safety for a product, information must not only flow seamlessly from affiliates to central, cross-functional teams, but back again. Any break in this information flow exposes a company to the possibility of being unable to identify or react to a safety issue in an effective, timely manner. Often, the challenge is that local safety resources do not report into the global function nor are they part of local medical teams. In addition, the setup may differ from affiliate to affiliate including situations where affiliates may rely entirely on external vendors. The end result is inconsistent awareness, unclear responsibilities, and limited means to resolve issues without having to escalate them to the highest levels of the organization.
Designing effective affiliate governance requires multi-functional stakeholder buy-in supported by change management to ensure the model is successfully implemented globally and ultimately embedded into an organization’s way of working.
What Affiliate Governance includes
- Design of an efficient, future-resilient operating model that supports the company’s strategic goals
- Seamless integration with other governance structures
- Impact analysis on existing procedures and ways of working
- Cross-functional stakeholder engagement
- Change management to ensure implementation success
Benefits – how Navitas can help
- Fit-for-purpose governance model with clear escalation paths and decision framework to support prompt, cross-functional decision making
- Globally consistent governance enabling improved oversight
- Integration of operating model into controlled procedures for inspection readiness
- Rollout, training, and measuring success to ensure governance has been embedded to achieve long-term benefits