Medical Marijuana and Drug Safety

/ May 07, 2019

Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.

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Signal Detection and Signal Management

/ Mar 27, 2019

Dr. W. Mark Riddle, M.D explores signal detection and signal management in Pharmacovigilance.

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Guide to Causality Assessment

/ Mar 20, 2019

What information should be examined in the study and work up of ADRs to determine whether the reaction is likely due to the drug or not.

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UK and EMA Inspections Update 2019

/ Mar 05, 2019

Bart Cobert reviews the changes and updates happening with UK and EMA inspections.

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Safety Reporting: Why We Do What We Do

/ Feb 07, 2019

We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.

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Brexit Update (again)

/ Jan 28, 2019

An update on the status of Brexit and the EMA move to Amsterdam.

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Confusions in Drug Safety & Pharmacovigilance

/ Dec 27, 2018

Bart Cobert addresses confusing areas in Drug Safety and Pharmacovigilance including Brexit, basic terminology, date formatting and others.

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Language and Translations in PV

/ Nov 27, 2018

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

/ 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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