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.

Is Real-Time Analytics Right for Your Organization?

Michael Dean / Oct 31, 2017

Big Data has been around for years, but the concept of real-time analytics has remained a challenge. But with current technological innovations, including automation and AI, that's all changing.

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.

Risk Management: Anticipate > Eliminate > Mitigate

Stuart Watson / Aug 10, 2017

Risk. From the time we wake up, we are faced with risks. Knowingly or not, our waking hours are spent trying to either eliminate or mitigate those risks.

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.

When Medical Information Becomes a Drug Safety Issue

Chris O'Shaughnessy / Jun 27, 2017

Closely-tied Medical Information and Drug Safety departments, with a seamless adverse event intake and hand-off processs, offer better quality control, scalability and risk mitigation.

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.