Tag Archive: ema

Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

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Brexit, Again

Brexit, Again

The UK has given official notice that they will withdraw from the EU. With Brexit seemingly moving ahead, Bart Cobert looks at its effects on the world of pharmacovigilance.

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Remote PV Audits & Inpsections

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

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Brexit and Pharmacovigilance

What effect will Brexit have on the world of Pharmacovigilance?

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EMA GPVP Module V – Risk Management: Draft Revision 2

In February 2016 the EMA released a draft of the revisions for the new version of Module V on Risk Management.

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Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work[…]

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Monitoring Medical Literature: EU Changes

The EU and FDA have required Marketing Authorisation Holders (MAHs) to monitor medical literature for adverse drug reactions for many years. The EMA has finally put forth the details of its new system to monitor medical literature for MAHs.

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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: 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: 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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