Tag Archive: Pharmacovigilance

Language and Translations in PV

Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.

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EMA and Brexit Yet Again: Part 3

Bart Cobert highlights the ongoing saga with EMA and Brexit. In this post, he elaborates on the lack of a current Brexit deal between the EU and the UK.

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EMA and Brexit Yet Again: Part 2

Another update from Bart Cobert regarding the ongoing Brexit saga.

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EMA and Brexit Yet Again Part1

EMA and Brexit Yet Again: Part 1

The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.

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When is a Signal Not a Signal?

When is a Signal Not a Signal?

Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.

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DMCs and SACs

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

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Data Security, Protection and the US-EU Privacy Shield: Part 2

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

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Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

Exploring the role of the Medical Monitor in the clinical research process.

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Data Security and Privacy Part 1

Data Security, Protection and the US-EU Privacy Shield: Part 1

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

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Going 75 Miles an Hour

Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.

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