Tag: ema

Tag: ema

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.

September 14, 2017
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.

August 22, 2017
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.

July 21, 2017
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.

March 29, 2017
Brexit and Pharmacovigilance

What effect will Brexit have on the world of Pharmacovigilance?

July 22, 2016
EMA GPVP Module V – Risk Management: Draft Revision 2

In February 2016 the EMA released a draft of the revisions for the new version of Module V on Risk Management.

April 20, 2016
Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work well. However, there are some…

November 13, 2015
Monitoring Medical Literature: EU Changes

The EU and FDA have required Marketing Authorisation Holders (MAHs) to monitor medical literature for adverse drug reactions for many years. The EMA has finally put forth the details of its new system to monitor medical literature for MAHs.

August 6, 2015
Bart’s Corner: EU Proposals on Updates for Good PV Practices

On September 15, 2014, the EMA published proposals on changes to the Good Pharmacovigilance (PV) Practices covering revisions of Module VI on the management and reporting of adverse reactions In particular post-authorisation safety studies and on Module III on new Union procedures for pharmacovigilance inspections. There is a request for public comment. In a guideline…

September 29, 2014

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