Tag Archive: ema

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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Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

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Brexit, Again

Brexit, Again

The UK has given official notice that they will withdraw from the EU. With Brexit seemingly moving ahead, Bart Cobert looks at its effects on the world of pharmacovigilance.

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Remote PV Audits & Inpsections

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

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