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Drivers, Pedestrians, and ICH Q9

The world is a dangerous place.

Risks are looming all around us.

You Dodge one ball just to find yourself worrying about another one.

But not all risks are of the same color. Some shine Red from the screen, others are minor and materialize daily, and some go unnoticed or unheard of forever…

We all know intuitively how risk management works: You cross the street and that car might hit you. It's not very likely, but you take it seriously and look both ways, as the consequences might be life or death. If you are the driver, you are not likely to be physically injured, but the lifelong agony of hurting someone else, and even potential incarceration, are severe outcomes nonetheless.

Both parties would agree that this event should be avoided at all costs- but the Preventive Actions each one needs to take are very different. Even though everyone must put down their phones when they roam around in the streets, the driver holds a different kind of ethical responsibility in this case as he is the one behind the wheel.

People working in the Pharma industry are the drivers of the Pharmaceutical products they develop and deliver. Like any medical intervention, Pharmaceutical products offer us cures to devastating diseases, but inherently pose some level of risk and side effects.

The core guideline we follow to properly manage these risks is ICH Q9, and it has been revised recently to reflect the way the industry has evolved since its first inception (links inside).

For example, the guideline now covers the aspect of Subjectivity in perceiving Risk and how to account for it in our day-to-day work, since not all risks are as clear-cut as the one presented above and different stakeholders may view it differently.

One thing is for sure- no matter what your role is in the company- remember your ethical obligation to the people that trust you with their health and do your best to see the big picture every step of the way.



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