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Bart Cobert highlights the intricacies of signal detection. Including those instances in which a signal may not be a signal.
Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).
Exploring the role of the Medical Monitor in the clinical research process.
Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.
Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.
Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 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 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.
Many US patients are obtaining drugs from online and foreign pharmacies. Bart Cobert examines this trend, and its impact on drug safety.
The EU is in turmoil as the Brexit EMA relocation continues to percolate, particularly behind closed doors. Also EU inspections are being discussed.