Bart Cobert

Bart Cobert

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.

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[…]

Read More

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[…]

Read More

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[…]

Read More

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[…]

Read More

New EU Draft Guideline on Pharmacovigilance Inspections “We are here to help you…”

/ Aug 06, 2012

What is this about?: In late June 2012 the EMA released its “Module III” on PV inspections.  This is a draft guideline due to be finalized by year end with[…]

Read More