Tag Archive: drug safety

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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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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EMA Move

EMA Move – The Details

It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.

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FDA Adverse Events Reporting System (FAERS)

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

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What You Need to Know About Measuring Customer Engagement

Measuring customer engagement should not be limited to "traditional" marketing metrics. Measurement should include customer service metrics such as accessibility, quality, and voice of the customer (VOC).

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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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