Tag Archive: drug safety

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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When Medical Information Becomes a Drug Safety Issue

Closely-tied Medical Information and Drug Safety departments, with a seamless adverse event intake and hand-off processs, offer better quality control, scalability and risk mitigation.

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AEs in Children

Drug Safety and AEs in Children

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

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Phase I Disasters … And Some Good News

Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.

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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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CURES Act of 2016 and Drug Safety

A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act - and its implications for drug safety.

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PMCs and PMRs

PMCs and PMRs: Some Good News

Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

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Timely Reporting to the FDA

Bart Cobert examines 2 recent cases of late reporting of clinical trial information to the FDA and other federal agencies.

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FDA’s Drug Safety Report

A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.

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PV Inspection Update

Pharmacovigilance inspections by health authorities remain a hot topic for pharma companies.

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