Tutorials are not included in the meeting registration and require a separate registration fee.

Even if safety is everyone’s responsibility, this message is sometimes lost in the complexity of day-to-day business activities of a pharmaceutical organization. Health Authorities have issued 483s and warning letters directing companies to establish safety governance models to assure that patient safety is always front and center regardless other strategic and operational priorities.  A company Safety Governance Model should be:

• Cross-functional – Safety is every employee’s and function’s responsibility
• Across the extended enterprise – Responsibility extends to partners,  suppliers, affiliates and distributors
• Leadership-driven – The governance model is led by senior leadership, and includes clinical, medical, quality and safety officers
• Periodic and predictable – the committees and processes are executed on a periodic basis as defined in the charters and SOPs
• Inclusive of people, process and technology – The model embodies organizational structure, safety-related processes and tools and technology to support patient safety

During the tutorial, instructors will present a case study on implementing a safety governance model.