FDA’s Drug Safety Report

A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.

Monitoring Medical Literature for Drug Safety

Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.

Making Sense of Social Media Conversations

Phil highlights the relevance of social media monitoring and engagement in the healthcare industry.

SAE Reporting for Outsourcing Facilities (Compounders)

Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)

Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Compliance, Quality & Cost: Why Outsourcing Clinical Trial Support Makes Sense for Start-Up and Mid-Sized Drug Manufacturers Clinical development of a drug or device from discovery through post-marketing approval requires a vast amount of time and resources. During the clinical trial phase, requirements and regulations imposed by governing regulatory bodies[…]

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[…]

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?

Seriousness, Expectedness and Investigator Brochures

There is some confusion that I have observed in how Serious Adverse Events (SAEs), Adverse Events (AEs) and expectedness are handled in Investigator Brochures (IBs). First a quick review of the concept of the IB. The basic requirements are described in ICH E6 which is used in most countries now.[…]

Bart’s Corner: French Breast Implant Safety Scandal

There is an ongoing safety issue (read: scandal) in France regarding the use of non-medical grade silicone in breast prosthesis implants.This is a scandal that has been playing out now for about four years. There is much information available in both English and French. There is a good summary on[…]

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[…]

Tag Archive: adverse events

FDA’s Drug Safety Report

Monitoring Medical Literature for Drug Safety

Making Sense of Social Media Conversations

SAE Reporting for Outsourcing Facilities (Compounders)

Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Bart’s Corner: PV Crises

Bart’s Corner: Drug Safety Stress Tests

Seriousness, Expectedness and Investigator Brochures

Bart’s Corner: French Breast Implant Safety Scandal

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

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