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.

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[…]

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