Tag: ema

  • Bart’s Corner: Update on EMA Risk Management Plans (RMPs)

    Bart’s Corner: Update on EMA Risk Management Plans (RMPs)

    In April of this year the EMA announced the first public summary of an RMP, in this case for the drug Neuraceq [florbetaben (18F)] The EMA also published an update of their webpage on RMPs, which noted that the revision to the Good PV Practice RMP module – Module V – came into effect on…

  • Bart’s Corner: EU Pharmacovigilance Inspection Update

    Bart’s Corner: EU Pharmacovigilance Inspection Update

    Several documents were published by the EMA and went into effect in June 2014 regarding EU Pharmacovigilance (PV) inspections. Some of the more important points are summarized here: Inspection Findings Impacting the Benefit-Risk Profile The Pharmacovigilance Risk Assessment Committee (PRAC) adopted a new procedure entitled: “Union procedure on the management of pharmacovigilance inspection findings which…

  • Data Monitoring Committees: Observations & Issues – Part I

    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 Service. This posting and the…

  • Bart’s Corner: EU Regulatory Updates

    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 interest to us in the…

  • Safety Items in the News

    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 a proposed study on direct…

  • Quality (QA QC QMS) Deficiencies

    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 and Europe and, sad to…