EMA and Brexit Yet Again: Part 1

Bart Cobert / Aug 15, 2018

The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.

DMCs and SACs

Bart Cobert / Jun 07, 2018

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

W. Mark Riddle, M.D. / Apr 26, 2018

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

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

Bart Cobert / Mar 29, 2018

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

Going 75 Miles an Hour

Bart Cobert / Feb 15, 2018

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

Expanded Access Trials, IITs and Safety Risks

Bart Cobert / 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.

EMA Move – The Details

Bart Cobert / 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.

FDA Adverse Events Reporting System (FAERS)

Bart Cobert / 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.