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Tag Archive: adverse events
Monitoring Medical Literature for Drug Safety
Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.
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Making Sense of Social Media Conversations
Phil highlights the relevance of social media monitoring and engagement in the healthcare industry.
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SAE Reporting for Outsourcing Facilities (Compounders)
Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)
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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[…]
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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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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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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.[…]
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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[…]
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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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Excipients and Inactive Ingredients in Drugs & Drug Safety
In our world of drug safety and PV, we don’t think much about inactive ingredients and excipients found in drug products. In fact, we don’t even know which ones are in the drugs we take, make, sell and prescribe, and we may not even be sure where to find out[…]
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