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Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.
Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.
Dr. W. Mark Riddle, M.D explores signal detection and signal management in Pharmacovigilance.
What information should be examined in the study and work up of ADRs to determine whether the reaction is likely due to the drug or not.
Bart Cobert reviews the changes and updates happening with UK and EMA inspections.
We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.
An update on the status of Brexit and the EMA move to Amsterdam.
Bart Cobert addresses confusing areas in Drug Safety and Pharmacovigilance including Brexit, basic terminology, date formatting and others.
Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.
Bart Cobert highlights the ongoing saga with EMA and Brexit. In this post, he elaborates on the lack of a current Brexit deal between the EU and the UK.
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