Tag Archive: ema

Different Regulatory Actions from Different Agencies

Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.

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UK and EMA Inspections Update 2019

Bart Cobert reviews the changes and updates happening with UK and EMA inspections.

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Brexit Update (again)

An update on the status of Brexit and the EMA move to Amsterdam.

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Language and Translations in PV

Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.

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EMA and Brexit Yet Again: Part 3

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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EMA and Brexit Yet Again: Part 2

Another update from Bart Cobert regarding the ongoing Brexit saga.

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EMA and Brexit Yet Again Part1

EMA and Brexit Yet Again: Part 1

The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.

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DMCs and SACs

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

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EMA Move

EMA Move – The Details

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.

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EU Update: EMA Relocation & EU Inspections

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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