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As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.
Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.
The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.
A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act - and its implications for drug safety.
Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).
Bart Cobert examines 2 recent cases of late reporting of clinical trial information to the FDA and other federal agencies.
A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.
Pharmacovigilance inspections by health authorities remain a hot topic for pharma companies.
In Part 1 we talked about concepts and starting the preparation for job hunting. Here are the next steps.
Interested in a career in Pharmacovigilance?