EU Update: EMA Relocation & EU Inspections

/ Sep 14, 2017

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

/ Aug 22, 2017

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

/ Jul 21, 2017

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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AEs in Children

Drug Safety and AEs in Children

/ Jun 16, 2017

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

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Phase I Disasters … And Some Good News

/ Apr 27, 2017

Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.

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Remote PV Audits & Inpsections

Remote PV Audits & Inspections

/ Mar 29, 2017

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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CURES Act of 2016 and Drug Safety

/ Feb 03, 2017

A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act - and its implications for drug safety.

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PMCs and PMRs

PMCs and PMRs: Some Good News

/ Jan 05, 2017

Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

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Timely Reporting to the FDA

/ Nov 22, 2016

Bart Cobert examines 2 recent cases of late reporting of clinical trial information to the FDA and other federal agencies.

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FDA’s Drug Safety Report

/ Oct 19, 2016

A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.

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