UK and EMA Inspections Update 2019

/ Mar 05, 2019

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

Read More

Brexit Update (again)

/ Jan 28, 2019

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

Read More

Confusions in Drug Safety & Pharmacovigilance

/ Dec 27, 2018

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

Read More

Language and Translations in PV

/ Nov 27, 2018

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

Read More

EMA and Brexit Yet Again: Part 3

/ 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.

Read More

EMA and Brexit Yet Again: Part 2

/ Sep 05, 2018

Another update from Bart Cobert regarding the ongoing Brexit saga.

Read More
EMA and Brexit Yet Again Part1

EMA and Brexit Yet Again: Part 1

/ Aug 15, 2018

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

Read More
When is a Signal Not a Signal?

When is a Signal Not a Signal?

/ Jul 18, 2018

Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.

Read More

DMCs and SACs

/ Jun 07, 2018

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

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

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

/ 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

Read More

Blog Signup