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Causation: the basis for pharmacovigilance

Published on August 31, 2023   47 min

A selection of talks on Clinical Practice

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0:00
Hello. I'm Ralph Edwards. In the past, I have been a professor in medicine for many years I've worked in the area of adverse reactions to medicine and toxicology. Basically I'm a Clinical toxicologists and have worked with as I say adverse drug reactions for a long time as director of the UMC which is a collaborating center for WHO and they manage the database of adverse reactions, global adverse reactions for the whole world really, which we get adverse reactions from about 130 countries and for a long time several decades and with the results that we have around coming up to 40 million adverse reactions in the global database. And its on that background I have based this talk starting with the title, which is causation. The basis for pharmacovigilance.
1:23
That's because pharmacovigilance starts with looking at each individuals report for a suspected adverse reaction from a particular drug. Now the problem is how do we assess that report. Is it worth starting a clinical trial on that adverse reaction or a group of adverse reactions, just where do we start? Causation is the first thing. The report could be thought to be an adverse reaction but it could be another disease, it could be a chance effect, it could be anything. I'm going to go through this talking about aspects of causation and how the subtitle here it's complex and challenging subject.

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