Category: Regulatory
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RWE and FDA: Six Years of the US Food and Drug Administration’s Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation
Congress mandated the creation of a postmarket Active Risk Identification and Analysis (ARIA) system containing data on 100 million individuals for monitoring risks associated with drug and biologic products using data from disparate sources to complement the US Food and Drug Administration’s (FDA’s) existing postmarket capabilities. We report on the first 6 years of ARIA… Read more
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Book: Post-Authorization Safety Studies of Medicinal Products: The PASS Book and Pharmacoepidemiology
Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well… Read more
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Book: Pharmacoepidemiology And Therapeutic Risk Management
Pharmacoepidemiology And Therapeutic Risk Management: Hartzema, Abraham G., Tilson, Hugh H., Chan, K. Arnold: 9780929375304: Amazon.com: Books Read more
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Guidelines: ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission… Read more