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Tag Archive: ema
Data Monitoring Committees: Observations & Issues – Part I
Data Safety Management Boards (DSMBs), also known as Data Monitoring Committees (DMCs), are a complex issue. They are described in two similar documents, one from the FDA from 2006 and the other from the EMA. Another interesting document on these committees has been put out by the UK National Health[…]
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Bart’s Corner: EU Regulatory Updates
EMA Working Programme for 2014 In December 2013, the EMA published its work program for 2014. It covered the many areas that the agency supervises and regulates. Much of the document is devoted to GMP, operational issues and other non-PV areas. But some comments in the PV sections are of[…]
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Safety Items in the News
Several safety items have been in the news recently and are summarized here. Direct-To-Consumer Safety In February the FDA published a notice in the Federal Register (see: https://telerx.bz/4q) entitled: “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements”. The FDA is requesting comments within 60 days. This is[…]
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Quality (QA QC QMS) Deficiencies
In May of this year I did a posting on the Quality Management Systems (QMS) that are obligatory for DS/PV departments based on FDA’s Quality Manual and the EMA’s Good PV Guidelines Module 1. Since then I have done many audits of drug safety and PV groups around the US[…]
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