Expanded Access Trials, IITs and Safety Risks

/ 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.

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EMA Move

EMA Move – The Details

/ 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.

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FDA Adverse Events Reporting System (FAERS)

/ 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.

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Online Drug Safety

Safety of Drugs Bought Abroad or Online

/ 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.

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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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When Medical Information Becomes a Drug Safety Issue

/ 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.

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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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