Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.
Bart Cobert gives his pharmacovigilance point of view on a recent paper on FDA approval timelines and drug safety issues.
Bart Cobert highlights the most important changes in the recently revised FDA draft guidance on PMRs.
Bart Cobert covers several issues involved in setting up the proposed “Safe Importation Plan” which aims to allow US consumers to get safe and cheaper drugs.
Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.
Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.
Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.
We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.
Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.