Another update from Bart Cobert regarding the ongoing Brexit saga.
The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.
Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).
Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance
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.