It's good for the customer, it's good for the industry, and it deserves to be embraced wholeheartedly

Regulation aims to keep the public safe and the playing field level.  We used to marginalise it, as an irksome extra task, its only function to satisfy the regulators.  That was bad business, because compliance - being seen to do the right thing - doesn't come cheap.  And, when you invest in any activity, you have to see added value.  Today, most companies are integrating pharmacovigilance (PV) into the mainstream operation.  It brings performance benefits, and compliance date comes out automatically.  The industry is less defensive too: we've learned that when things go wrong, it's no good wriggling.  We simply own up and fix it.  But what's this?  Just as we think we're sorted, the regulators (starting with the FDA) shift the goalposts.  No, don't groan yet: wait until you've heard the plan!

To read this article in full, please click on the pdf link below:

Good News Regulations just got tougher.pdf