ACR622

Describe the components of a Quality Management System.

Define the various phases of a medical therapy life cycle and identify primary deliverables for each phase.

Define cross-functional roles within a development team and their major responsibilities.

Specify clinical research, regulatory, and quality roles, responsibilities, and deliverables within each phase of a medical therapy life cycle.

Describe risk mitigation processes.

Define the various sources of performance and safety information developed during the development of a medical therapy and identify how to utilize this information.

Describe the current medical therapy development climate, including regulatory reform, comparative effectiveness research, and the reimbursement environment.