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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.

Clinical Trials & REMS in the Time of Corona: FDA & MHRA Advice and Guidance

/ Apr 09, 2020

Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.

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Does Rapid FDA Approval Produce Drug Safety Issues?

/ Mar 16, 2020

Bart Cobert gives his pharmacovigilance point of view on a recent paper on FDA approval timelines and drug safety issues.

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Clintrials.gov Update

/ Feb 11, 2020

Bart Cobert on the importance of publishing clinical trials data and implications on pharmacovigilance.

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Pharmacovigilance 2030

/ Dec 11, 2019

This is an interesting article looking at what PV will be in the year 2030.

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FDA Draft Guidance on PMRs

/ Nov 24, 2019

Bart Cobert highlights the most important changes in the recently revised FDA draft guidance on PMRs.

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Ranitidine – What Happened and What Do We Learn?

/ Oct 31, 2019

Bart Cobert explores several important points to take from the still ongoing signal and safety issue with Renitidine recall.

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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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