Vaping – A Serious Safety Signal

/ Oct 07, 2019

Bart Cobert discusses the major safety issue in the US on e-cigarettes and vaping.

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Importing Canadian Drugs to the US

/ Aug 29, 2019

Bart Cobert covers several issues involved in setting up the proposed "Safe Importation Plan" which aims to allow US consumers to get safe and cheaper drugs.

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No-No’s in Drug Safety

/ Aug 13, 2019

An overview covering a number of things to avoid doing when it comes to drug safety.

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Different Regulatory Actions from Different Agencies

/ Jun 27, 2019

Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.

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Reporting and Not Reporting Data

/ Jun 03, 2019

Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.

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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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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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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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