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Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.
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.
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 examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).
It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.
The EU is in turmoil as the Brexit EMA relocation continues to percolate, particularly behind closed doors. Also EU inspections are being discussed.
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