Regulatory Open Forum

It is my experience that we often get too focused on "requirements" when doing risk management. 

An important question to ask is "who is taking the risk?"

This came up in a recent Le'ts Talk Risk! conversation with Dr. Adam Saltman. He has a unique perspective on this topic as a physician and a regulatory.

Here are couple of other key highlights from our discussion:

1. Risk is evaluated in the context of benefits
2. Regulators review clinical data as a proxy to evaluate benefit-risk
3. There is a disconnect between patients, manufacturers and regulators
4. Engage top management to gain buy-in for voice of the patient throughout device lifecycle

If you are interested, an audio recording of our discussion is available here

The most important question for risk management: who is taking the risk?

Please share your thoughts in comments below.

Best regards

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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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