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Case Processing Deficiencies

In our last posting we discussed problems in quality management systems found during audits and inspections.  In this posting we want to discuss problems seen during inspections regarding the processing of individual case safety reports (ICSRs). Health agencies, in particular the FDA and the EMA/member states, have detailed requirements on how to process individual case…

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Risk

In drug safety, pharmacovigilance, drug development and many other areas that we are involved in there are extensive discussions and even more extensive documents written to evaluate benefits and risks.  Most of us don’t think too much about the concept of risk itself from a more theoretical and conceptual point of view.    Let’s take a…

Take a Step Back and Look. The World is Changing Around You.

We are often too busy to have the time to take a step back and see what is going on around us. There are macroeconomic, demographic, social and climate trends that are going to have a major impact on how we support patients and consumers in the not-so-distant future. Exploding Middle Class The middle class…

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Generic Safety Labeling: FDA’s new regulation – Part 2

In Part 1 we looked at the old and the proposed new regulation on generic labeling.  Now we will take a look at possible implications. Comments and Implications The new regulation will change the landscape for all the stakeholders. Branded Companies For branded companies there will be good and bad points. Routine PV and legalities…

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Operational Tweaks Can Greatly Reduce PHI Breach Risk

After four years of anticipation, 45 CFR Parts 160 and 164, or HIPAA’s Ominibus Rule as it is more commonly known, went into effect on March 26, 2013, with corporate compliance required by September 23, 2013. Omnibus puts into law many things left unclear in previous HIPAA-related rulings, including requiring business associates of covered entities…

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Generic Safety Labeling: FDA’s new regulation – Part 1

On November 8, 2013 FDA published an announcement in the Federal Register regarding new labeling requirements for generic drugs.  (See http://telerx.bz/3n) It was officially published November 13, 2013.  There will be a 60 day comment period and then, presumably, FDA will make the regulations final and they will take effect – probably early to mid 2014…

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The Old Enriched By The New

SOCAP International 2013 Annual Conference October 27 – 30, Scottsdale, Arizona In a land of timeless natural wonders—the breathtaking Arizona mountain views, the amazing red rock formations of Sedona, and the simple beauty of the Scottsdale desert — over 500 conference attendees met for the 2013 SOCAP International Annual Conference. These steadfast wonders of nature…

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