It is important to set-up validation strategy of analysis systems in drug development in pharmaceutical industry. One of the hot topics in open source software(OSS) utilization in this space is R package validation. Risk-based approach of the validation is commonly employed. In this presentation, we summarize the available tools (e.g. riskmetric, etc.) for risk assessment in the approach and discuss the points to consider. This is a presentation by phuse Japan open source technology WG.
Ryo Nakaya
Takeda
Risk Assessment Deep Dive
It is important to set-up validation strategy of analysis systems in drug development in pharmaceutical industry. One of the hot topics in open source software(OSS) utilization in this space is R package validation. Risk-based approach of the validation is commonly employed. In this presentation, we summarize the available tools (e.g. riskmetric, etc.) for risk assessment in the approach and discuss the points to consider. This is a presentation by phuse Japan open source technology WG.