AEs in Children

Drug Safety and AEs in Children

/ Jun 16, 2017

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

/ Apr 27, 2017

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

/ Mar 29, 2017

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

/ Feb 03, 2017

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

/ Jan 05, 2017

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

/ Nov 22, 2016

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

/ Oct 19, 2016

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

/ Sep 20, 2016

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

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Getting Started in Pharmacovigilance – Part 2

/ Jul 12, 2016

In Part 1 we talked about concepts and starting the preparation for job hunting.  Here are the next steps.

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Getting Started in Pharmacovigilance – Part 1

/ Jun 16, 2016

Interested in a career in Pharmacovigilance?

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