Tag Archive: Pharmacovigilance

Bart’s Corner: EU Proposals on Updates for Good PV Practices

On September 15, 2014, the EMA published proposals on changes to the Good Pharmacovigilance (PV) Practices covering revisions of Module VI on the management and reporting of adverse reactions In particular post-authorisation safety studies and on Module III on new Union procedures for pharmacovigilance inspections. There is a request for[…]

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Bart’s Corner: Escalating Signals and Safety Issues

In modern day pharmacovigilance (PV) and Drug Safety (DS), whether it is done in companies or health authorities, it is absolutely necessary to have in place a mechanism both to identify safety issues and then to act on them. There has been much discussion about the identification of safety issues[…]

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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[…]

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Bart’s Corner: The Sentinel and Mini-Sentinel Initiatives

In 2008 in response to criticism and some safety issues and product withdrawals, FDA took a look at itself – with some outside help such as the FDA Amendments Act (FDAAA). This new law mandated the FDA to establish an active surveillance system for monitoring drugs using electronic data from[…]

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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[…]

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Data Monitoring Committees: Observations & Issues – Part II

In Part 1 of this post we started the review of some practical issues in the management and functioning of DMCs. We conclude here. Pushback I have seen situations where the sponsor uses the DMC only grudgingly and really does not want the DMC to act as an independent body[…]

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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: 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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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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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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