EMA and Brexit Yet Again: Part 3

/ Oct 02, 2018

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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How are Empowered Nurses Changing the Pharma Industry?

/ Sep 13, 2018

Nurses today are in an optimal position to help pharma companies. Dr. Adele Mueller shares how empowering nurses empowers patients.

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EMA and Brexit Yet Again: Part 2

/ Sep 05, 2018

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

/ Aug 15, 2018

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?

/ Jul 18, 2018

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

/ Jun 07, 2018

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

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Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

/ Apr 26, 2018

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

/ Mar 29, 2018

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

/ Feb 15, 2018

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

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Expanded Access Trials, IITs and Safety Risks

/ Jan 25, 2018

Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 2017.

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