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PSP Publishes the First Modeling and Simulation Report from Japan's PMDA
The perspective "Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective" by Sato and colleagues is the first report on the current state of modeling and simulations (M&S) in Japan's Pharmaceutical and Medical Device Agency (PMDA) in a peer-reviewed journal. It is also the first report by the PMDA published in CPT: Pharmacometrics & Systems Pharmacology (PSP), following several impactful reports on regulatory quantitative sciences from...[read more
EMA Publishes a Commentary on the MID3 White Paper
The value of integrated modeling and simulation (M&S) as a decision-making tool is well established across a range of industries and disciplines, such as engineering, finance, aerospace, and weather forecasting....[read more
PSP Publishes New Databases for Pharmacometrics & Systems Pharmacology

Most people probably associate the disciplines of Pharmacometrics and Systems Pharmacology in the first instance mainly with modelling and simulation.  However, decades ago computer scientists had already pointed out the “garbage-in-garbage-out” (GIGO) principle, emphasizing the reliance of modelers on high-quality data. ...[read more]

Although the critical role of the immune system in cancer has long been recognized, the development of novel oncological pharmacotherapies through specifically targeting the immune system is a relatively new area of research. Key challenges for the effective translation of emerging science ...[read more]

    Friday, 5 May 2017, 11:00AM-12:00PM EDT (UTC -4)

    Modeling and simulation has become an integral and expected part of internal and regulatory decision making, as illustrated by regulatory guidelines and industry best practice guidelines. For example, as a response to a request from the European Medicines Agency (EMA), the...[read more
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