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| Issue |
Title |
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| Vol 4, No 2 (2024) |
International experience in drug assessment for rare diseases: flexibility of approaches |
Abstract
PDF (Rus)
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K. S. Radaeva, A. S. Kolbin |
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| Vol 4, No 2 (2024) |
Analysis of real-world data for medical device evaluation: Chinese manual |
Abstract
PDF (Rus)
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A. R. Kasimova, Wenlong Zhao |
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| Vol 3, No 3 (2023) |
ICH Reflection paper on proposed international harmonization of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of drugs |
Abstract
PDF (Rus)
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K. S. Radaeva, R. R. Niyazov |
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| Vol 3, No 3 (2023) |
Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making |
Abstract
PDF (Rus)
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Ksenia S. Radaeva, M. V. Pchelintsev |
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| Vol 3, No 2 (2023) |
Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
Abstract
PDF (Rus)
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V. G. Borovskaya, A. R. Kasimova |
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| Vol 3, No 2 (2023) |
Decentralized clinical trials: regulatory perspectives in Russia and the EAEU |
Abstract
PDF (Rus)
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M. A. Borzova, S. V. Semina |
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| Vol 2, No 4 (2022) |
NICE guidance to working with real-world data |
Abstract
PDF (Rus)
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A. Sh. Motrinchuk, A. R. Kasimova, E. A. Novoderezhkina |
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| Vol 2, No 4 (2022) |
DARWIN EU® is an electronic platform for the collection and analysis of health data in the European Union |
Abstract
PDF (Rus)
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K. S. Radaeva, E. V. Verbitskaya |
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| Vol 2, No 3 (2022) |
Analysis of RWD/RWE recommendations and guidelines for 2021. International experience on the example of USA |
Abstract
PDF (Rus)
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A. Kurylev |
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| Vol 2, No 3 (2022) |
Use of real-world data for decision making in Canada and United Kingdom |
Abstract
PDF (Rus)
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P. A. Mukhortova, P. V. Gorkavenko, Yu. V. Strunina, V. V. Omelyanovskiy, V. V. Kalinichenko |
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| Vol 2, No 2 (2022) |
SENTINEL SYSTEM – electronic system for collecting real-world data |
Abstract
PDF (Rus)
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E. O. Eremenko, M. I. Baranova |
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