E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]
Posts Tagged ‘SOPs’
IT Solutions From A Vendor Who Really Gets “Regulated Industry”
Similar to many industries, but arguably one of the most challenging, the life sciences sphere undergoes regulatory and compliance changes. Each country, group of nations, and regulatory body proposes different guidelines at different times. And, even though it could take several years for the changes to go into effect, when they do, you’d better […]
Is Risk-Based Monitoring Just A Fad?
While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic…
When The FDA Is Concerned About Your Ability To Monitor Drugs
A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]
FDA Warning: Don’t Get Caught With Bad SOPs
Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.”