Going 75 Miles an Hour

Bart Cobert / Feb 15, 2018

Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.

Expanded Access Trials, IITs and Safety Risks

Bart Cobert / Jan 25, 2018

Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 2017.

EMA Move – The Details

Bart Cobert / Dec 19, 2017

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.

FDA Adverse Events Reporting System (FAERS)

Bart Cobert / Nov 16, 2017

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

Safety of Drugs Bought Abroad or Online

Bart Cobert / Oct 26, 2017

Many US patients are obtaining drugs from online and foreign pharmacies. Bart Cobert examines this trend, and its impact on drug safety.

EU Update: EMA Relocation & EU Inspections

Bart Cobert / 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.

Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert / 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.

Brexit, Again

Bart Cobert / 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.

Drug Safety and AEs in Children

Bart Cobert / 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.