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2 day in-person workshop (November 11-12, 2015)
Introduction to Pharmacovigilance: Clinical and Post-Marketing With increasing concerns about drug safety, pharmacovigilance during both clinical development and after marketing approval has been granted has increasingly become a focus within individual pharmaceutical/biotech companies This workshop is designed to extensively cover the gamut of pharmacovigilance beginning with Phase I studies through to lifecycle management. The regulatory structures surrounding pharmacovigilance will be included with a discussion of the means by which safety data are collected, analyzed, and acted upon. Signaling techniques including Senior-Guo plots, trending analyses, proportionality analyses, and data mining will be considered. It is designed for novices and advanced users alike and benefits those in management who must evaluate and act upon analyses and reports from the pharmacovigilance department. These include those in pre-clinical/toxicology, clinical development, clinical pharmacology, regulatory, and legal departments. Through numerous case studies, participants will review the processes involved in the detection and evaluation of potential safety signals and the means by which safety signals may be addressed, including the development of REMS. Pharmacoepidemiology studies will be introduced when appropriate. Some Pharmacovigilance training highlights....
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For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: info@fdamap.com
