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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.
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.
Another update from Bart Cobert regarding the ongoing Brexit saga.
The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.
Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.
Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).