Tag Archive: drug safety

Going 75 Miles an Hour

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

EMA Move – The Details

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)

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

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

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 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

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

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

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.

Phase I Disasters … And Some Good News

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

The Experience Matters.

As an industry leader in business process outsourcing, HCL Technologies delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.