Author: Tom
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Oncology: The Pathway for New Cancer Drug Access in Canada
Cancer treatment has evolved significantly over the past decade with the emergence of a multitude of new treatments across cancer types. Alongside the pace of drug discovery, the cost of cancer drugs has also increased. In the face of this growth in development and spending, it is crucial to have an understanding of the processes… Read more
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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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RWE and EMA
DARWIN EU delivers real-world evidence from across Europe on diseases, populations and the uses and performance of medicines. This enables EMA and national competent authorities in the the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product. Data Analysis and Real World Interrogation Network (DARWIN EU) | European Medicines Agency (europa.eu) Read more
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RWE and FDA
FDA has a long history of using what we currently call real-world data (RWD) and real-world evidence (RWE) to monitor and evaluate the postmarket safety of approved drugs. RWE has also been used historically to support effectiveness, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for… Read more
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Guidelines: Pharmacoepidemiology Practices (GPP)
Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and interpretation of pharmacoepidemiologic research. This paper represents the fourth version and supersedes previous versions. While the overall structure and nature of the… 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