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.

Drug Induced Liver Injury (DILI)

/ Nov 14, 2012

The liver is the first stop on the path a drug takes after oral ingestion.  From the liver’s “point of view”, drugs are like other exogenous agents and are handled[…]

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More PV Lessons from the News: Roche

/ Oct 31, 2012

In June 2012 the European Medicines Agency announced that they are working with other EU health agencies to investigate deficiencies in safety reporting at Roche.  This followed an inspection by[…]

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Injectable Steroids, Monster Energy and Predicting Earthquakes: Lessons For Drug Safety

/ Oct 24, 2012

Three seemingly unrelated issues in the news that touch marginally or not at all on drug safety nevertheless carry important lessons for those of us who do pharmacovigilance for a[…]

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Pharmacovigilance Fees?

/ Oct 17, 2012

A new issue has arisen that is being much talked about in the European Union but less so in the US, namely fees for pharmacovigilance activities paid to the health[…]

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Back to the Basics in PV

/ Oct 10, 2012

Since starting these postings we’ve had a lot of questions about some of the basics of drug safety.  So our thought is that this would be a good time to[…]

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FDA’s Internal SOP on How To Do An NDA Safety Review Part 3

/ Oct 03, 2012

We are continuing and finishing the review of one of the FDA’s critical internal SOPs:  MOPP 6010.3R: Attachment B: Clinical Safety Review of an NDA or BLA (Issued 12/14/2010; Posted[…]

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FDA’s Internal SOP On How To Do An NDA Safety Review Part 2

/ Sep 26, 2012

We are continuing the review of one of the FDA’s critical internal SOPs:  MOPP 6010.3R: Attachment B: Clinical Safety Review of an NDA or BLA (Issued 12/14/2010; Posted 12/14/2010). We[…]

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The FDA’s Internal SOP On How To Do An NDA Safety Review Part 1

/ Sep 18, 2012

One of the lesser known aspects of the FDA is that their SOPs are in the public domain and are available on-line.  They are found in the Manual of Policies[…]

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What Is The Right Size For A Safety Database?

/ Sep 10, 2012

An often asked question.  The answer depends on whom you ask. Ask the Chief Financial Officer (money does matter of course) and the likely answer is the smallest number of[…]

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The Wave – EMA’s New PSUR-PBRER

/ Aug 30, 2012

What is this about?: The EMA has released (June 2012) the new “Guideline on Good Pharmacovigilance Practices (GVP) – Module VII – Periodic Safety Update Reports”   which covers the new[…]

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