Fcpa Compliance Report

I continue my discussion of operationalizing your compliance program through the risk management process by considering risk-based monitoring. I continue this series based upon interviews with Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment and risk monitoring for the compliance profession.  Locwin said, “Risk-based monitoring is really about continuous, ongoing monitoring for those things which provide the most potential future risk to you. In other words, instead of a static risk registry that may come in part with forecasting, where you would say, “We’re trying to anticipate these risks.” By using risk-based monitoring to review issues on an ongoing basis, and the models that are behind the risk-based modeling, risk-based monitoring models, they’re continuously refined based on incoming data.”  The problem for many companies is they are siloed in not only their data but also in the systems. Locwin explained that