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

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

/ May 07, 2018

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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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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EMA Move

EMA Move – The Details

/ Dec 19, 2017

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)

/ Nov 16, 2017

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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