Tag Archive: drug safety

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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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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Getting Started in Pharmacovigilance – Part 1

Interested in a career in Pharmacovigilance?

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FDA Guidance on Biosimilar Labeling

Bart Cobert reviews the newly published FDA draft guidance for industry on Labeling for Biosimilar Products.

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Animal Health 101: Key Components of a Veterinary PV Program

As in the human medical sciences field, the world of veterinary PV is constantly evolving. Explore the 4 main components of an animal health PV program.

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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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