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.

Brexit and Pharmacovigilance

/ Jul 22, 2016

What effect will Brexit have on the world of Pharmacovigilance?

Read More

Getting Started in Pharmacovigilance – Part 2

/ Jul 12, 2016

In Part 1 we talked about concepts and starting the preparation for job hunting.  Here are the next steps.

Read More

Getting Started in Pharmacovigilance – Part 1

/ Jun 16, 2016

Interested in a career in Pharmacovigilance?

Read More

FDA Guidance on Biosimilar Labeling

/ May 19, 2016

Bart Cobert reviews the newly published FDA draft guidance for industry on Labeling for Biosimilar Products.

Read More

EMA GPVP Module V – Risk Management: Draft Revision 2

/ Apr 20, 2016

In February 2016 the EMA released a draft of the revisions for the new version of Module V on Risk Management.

Read More

The French Phase I Trial Disaster

/ Mar 30, 2016

Bart Cobert discusses the lessons learned from the recent Phase I trial disaster in France.

Read More
IND Safety Reporting

FDA’s Safety Assessment for IND Safety Reporting Draft Guidance

/ Feb 29, 2016

Bart Cobert examine's the FDA's latest guidance on Safety Assessment for IND Safety Reporting

Read More

FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

/ Feb 09, 2016

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.

Read More

PV Inspections of Contract Service Providers

/ Jan 21, 2016

An update on inspections by governments and health authorities of CROs and other pharma service providers.

Read More

EudraVigilance Stakeholder Change Management Plan

/ Jan 07, 2016

EMA Changes to EudraVigilance (EV), ICSR reporting and SUSAR reporting

Read More