9] Four cases of oxaliplatin-induced laryngospasm was reported in August, 2010 at the Netherlands pharmacovigilence
center and 85 cases were reported by the World Health Organization collaborating center.
Safety data, safety signals, and pharmacovigilence
findings may not be perceived as interesting to publishers and journal editors but are vital to understanding the risk-benefit of drugs and devices throughout the life-cycle of a product.
This concept, which was originally defined for the drug pharmacovigilence
in Western medicine (Alvarez-Requejo et al 1998), also has relevance to the domain of acupuncture.
Orlandi will be responsible for leading Clinical Development, Medical Affairs, Pharmacovigilence
and Regulatory Affairs for the Company, including its Phase 3 clinical trial program for flurpiridaz F 18.
Specific opportunities for influence lie in areas such as nomenclature/naming, labeling, pharmacovigilence
For example, in the post-marketing setting, should a sponsor receive a spontaneous safety report from their pharmacovigilence
activities, FDA guidance (page 7/8 in (13)) suggests that the label language take the following form:
From 2008 to 2009, Keller served as vice president of regulatory affairs and pharmacovigilence
for Medicis Pharmaceutical Corp.
Regulators will raise the bar for innovation, drug approvals and pharmacovigilence
More transparency over pharmacovigilence
data and reporting;
The final section contains a chapter on clinical toxicology (acute overdose management), regulatory aspects of safety assessment, and pharmacovigilence
Regulators will take a more proactive stance that will raise the bar for innovation and drug approvals and pharmacovigilence
will be the story.
A potential excess of AEs is often defined as any product-event combination with a score exceeding the specified threshold (FDA Guidance for Industry: Good Pharmacovigilence
Practices and Pharmacoepidemiologic Assessment, 2005).