Tag Archive: recalls

Adverse Events: Not Just a Concern for Healthcare

Frank Pettinato discusses the FDA database which catalogs adverse event and product complaint info for foods, dietary supplements, and cosmetics.

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3 Keys to Handling a Product Recall

Despite a company’s commitment to safe production and distribution practices, food recalls and other crisis situations can and do happen. The CDC estimates that every year in the U.S. alone, food-borne illness sickens 48 million people (or 1 in 6), sending 128,000 to the hospital and resulting in 3,000 fatalities.[…]

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PV / Drug Safety Crises

Bart’s Corner: PV Crises

This is a follow up to the previous posting on PV Stress Tests. During every PV person’s career, a “PV crisis” will arise. PV “crises” can occur in clinical trials or during marketing and may be of varying degree and type; so let’s define them first. Although the following are[…]

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Telerx Blog: Drug Safety Stress Tests

Bart’s Corner: Drug Safety Stress Tests

Could your drug safety department withstand a crisis or a “perfect storm” that puts severe stress on your department and company?

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To Outsource or Not To Outsource? That May No Longer Be a Question

The healthcare landscape is changing dramatically… and many changes are yet to come. As such, outsourcing has increased in an effort to drive down cost and comply with the ever-changing regulatory environment.   Here are 4 outsourcing trends in the pharmaceutical and healthcare industries: Crisis Management Recall Support: During any[…]

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Image courtesy of Stuart Miles/ FreeDigitalPhotos.net

Outsourcing’s Increasing Role in the New Healthcare Model

It comes as no surprise to anyone that the healthcare landscape has changed dramatically in recent years and there is little doubt that many changes are yet to come; and when they do we’ll have to be agile and adapt once again. Due to recent changes, many companies are facing[…]

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Preparing for the Consumer Impact of Your Recall

I arrived in Washington DC for day 1 of the CBI Product Recalls Summit and heard a lot of great information regarding the internal preparation for recalls.  I even participated in a mock recall exercise, which was very enlightening. My presentation, in collaboration with Richard Petruschke of Novartis Consumer Health[…]

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