UK and EMA Inspections Update 2019

Bart Cobert / Mar 05, 2019

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

Brexit Update (again)

Bart Cobert / Jan 28, 2019

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

Confusions in Drug Safety & Pharmacovigilance

Bart Cobert / Dec 27, 2018

Bart Cobert addresses confusing areas in Drug Safety and Pharmacovigilance including Brexit, basic terminology, date formatting and others.

Language and Translations in PV

Bart Cobert / Nov 27, 2018

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

EMA and Brexit Yet Again: Part 3

Bart Cobert / Oct 02, 2018

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.

EMA and Brexit Yet Again: Part 2

Bart Cobert / Sep 05, 2018

Another update from Bart Cobert regarding the ongoing Brexit saga.

EMA and Brexit Yet Again: Part 1

Bart Cobert / Aug 15, 2018

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

DMCs and SACs

Bart Cobert / Jun 07, 2018

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

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert / May 07, 2018

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance