Until a few months ago, few if any senior executives had personal experience managing a company during a pandemic. Making matters more difficult, there’s really no recent history to consult to determine what perils lie ahead, which processes worked, which didn’t, and how to plan for a recovery once the crisis passes.
Unfortunately, this uncertain environment seems likely to continue for the foreseeable future. We don’t know what will happen when businesses start to re-open, safety inspections resume, and regulatory enforcement discretion and emergency authorizations come to an end.
When it comes to following strict manufacturing practices and minimizing health risks, the pharmaceutical industry may be the most well-equipped business sector to respond to the types of challenges presented by the coronavirus. In fact, we’re looking to them to emerge as heroes in this crisis as they strive to develop effective treatments and vaccines for COVID-19.
But that doesn’t mean there’s no risk. In fact, their work may inadvertently open the door to more recalls and regulatory enforcement down the road. Why?
In a recent Pharmaceutical Outsourcing article I shared what I see as a “perfect storm of risks.”
I dive into much more detail on each of these matters in the full article, which I encourage you to read if you’re interested in what the post-pandemic regulatory world has in store for the pharmaceutical industry.
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