Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

/ Apr 26, 2018

Exploring the role of the Medical Monitor in the clinical research process.

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Data Security and Privacy Part 1

Data Security, Protection and the US-EU Privacy Shield: Part 1

/ Mar 29, 2018

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

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Going 75 Miles an Hour

/ Feb 15, 2018

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

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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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