Organizations that Deal with Pharmacovigilance and Drug Safety – Part 1

Bart Cobert / Dec 12, 2012

In an earlier post, we talked about the Uppsala Monitoring Centre (www.who-umc.org) in Sweden. This is the major organization (outside of governments) that deals almost purely with drug safety. Also[…]

Source Documents and Data Retention in Drug Safety

Bart Cobert / Dec 05, 2012

In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. It is available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf Although this document does not address drug safety[…]

The Uppsala Monitoring Centre (UMC)

Bart Cobert / Nov 28, 2012

There is an organization that has done basic, pioneering work in drug safety and pharmacovigilance and that today continues to play a unique role in this field. This organization is[…]

Pharmacovigilance and Pregnancy

Bart Cobert / Nov 21, 2012

Obviously, the safety of drugs in pregnant and breast-feeding women, the embryo/fetus and, less directly, the male partner are of paramount importance. Yet this is an area where little is[…]

Drug Induced Liver Injury (DILI)

Bart Cobert / 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[…]

More PV Lessons from the News: Roche

Bart Cobert / 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[…]

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

Bart Cobert / 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[…]

Pharmacovigilance Fees?

Bart Cobert / 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[…]

Back to the Basics in PV

Bart Cobert / 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[…]

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

Bart Cobert / 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[…]