The Risk Management Process in Compliance - Tom Fox Whitepaper

From the author:

This paper will focus on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecasting, risk assessment and risk-based monitoring for the compliance profession.

 The genesis of this paper began when I read a piece by Locwin in Contract Pharma’s Expert’s Opinion column, entitled “Pharma Life After Brexit”, where he posited that “forecasting has once again taken a hit for being less than accurate.” And this was before the US Presidential election. I was intrigued by his thoughts around forecasting and what (apparently) went wrong in the UK over Brexit. I immediately noted the implications for the compliance practitioner. This led to a series of interviews with Locwin leading to several podcasts and this paper.

At its heart, every business tries to plan for its future. It is a critical aspect of any management of any organization, non-profits, privately owned for profits and, of course, publicly traded companies. It is important that management be able to set out what it opines will happen in the next three, six, twelve and twenty-four months. Locwin said this “is really something that the businesses try to wrap their heads around in such a way that they can shunt resources where they think is appropriate in order to meet these future demands. Forecasting really at its heart is an educated guess and really as much as it becomes a reliable model more so and less so a guess, is based on the quality of the input data.” It is a process through which you are attempting to “prognosticate what the future will bring to you”. Unfortunately, forecast models are only as good as the data which are put into them or the GIGO (Garbage In, Garbage Out) Principal.

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