Bart Cobert

Bart Cobert

bcobert@gmail.com

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

Bart is a pharmacovigilance and drug safety consultant with 30 years in the pharmaceutical industry. He was a founding member and working group chair in ICH, and has written 4 textbooks on drug safety. Bart offers expertise in all areas of strategic pharmacovigilance including data management committees, mock Advisory Committee meetings, FDA & EMA/MHRA/AFSSAPS interactions, compliance, training, risk management (REMS/RMPs), crisis management, medical & safety analyses & white papers, and organizational change management. He is also a board certified gastroenterologist.

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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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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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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