Tag Archive: Pharmacovigilance

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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Brexit and Pharmacovigilance

What effect will Brexit have on the world of Pharmacovigilance?

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Monitoring Medical Literature for Drug Safety

Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.

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Getting Started in Pharmacovigilance – Part 2

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

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The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

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