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Intro
Topic Intro
The importance of risk-based TMF
What Regulatory Authorities are encouraging TMF teams to look for
The benefits of risk-based TMF
Things to think about when implementing a risk-based approach
First steps to risk-base TMF process success
The concept and development of a risk-management plan
Is a risk-based management plan necessary?
Patient safety and risk plan
What should you consider when implementing a risk-based approach process
Wrap-up & Risk-Based TMF management White Paper (link above)
Outro