GxP Lifeline November 2008 - Your Resource for Life Science Intelligence

November 2008

Video:

Using MasterControl for FDA Compliance

Feature Article:

Gems on REMS (Risk Evaluation and Mitigation Strategies)

For Pharmaceuticals:

Adverse Event Reports Hit Record High

For Medical Device:

Postmarket Surveillance - Are You Prepared for FDA's New Priority?

For Blood & Biologics:

U.S. Biovigilance Network - Hemovigilance System

News for Life Science Professionals

Good or Bad News for Clinical Professionals?

Did You Know?

Did you know that today's submission validation criteria are moving beyond the recommended industry standard?


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Gems on REMS

When I told my wife -- who is not in this line of work -- that I was chairing a conference on REMS (Risk Evaluation and Mitigation Strategies), she asked me what I was doing at an event about rapid eye movement. I can assure you that there was no REMS sleep allowed during this event.

A common question I get about REMS is - how is it different from what we used to call RiskMAPS? I see two main differences. The first, obviously and importantly, is that REMS has actual legislative language. And that's an important detail - but it's one-dimensional.


For Pharmaceuticals: Adverse Event Reports Hit Record High

According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been. These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.


For Medical Device: Postmarket Surveillance: Are You Prepared for FDA's New Priority?

FDA is focused on improving postmarket surveillance to optimize the identification, analysis, and use of postmarket information about medical devices. FDA has not enforced active PS requirements extensively historically, but the agency has signaled that this practice is likely to change. Elaine Tseng outlines what you need to know to remain compliant.


For Blood & Biologics: U.S. Biovigilance Network - Hemovigilance System

The U.S. Biovigilance Network, the nation's first and only nationwide data collection program for the transfusion and biological therapy communities, is preparing for a January 2009 launch of its pilot. The Network has raised more than $1 million in private donations and has also secured support from hospitals and blood centers across the country. AABB's Director of Data and Special Programs describes why the system is vital to the safety of our nation's blood supply.


News for Life Science Professionals: Good or Bad News for Clinical Professionals?

Clinical trials have never been simple endeavors of administration, especially where regulated transparency is concerned. The FDA for example has just increased the scope of trials in which specific clinical trials information must be reported. In other words, working in conjunction with clinical trials may have just become "more involved" for regulatory and/or quality professionals.


Did You Know?

Did you know that today's submission validation criteria are moving beyond the recommended industry standard and that anything from XML files to PDF files inherent in the creation and review of eCTDs require deep analysis? Are you confident that your submission will meet the right standards as requirements change constantly?



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