Results 11 to 20 of about 463,959 (219)
A plan on how to monitor and manage risks exists and is made accessible.
Pappalardo, Giusy +2 more
+80 more sources
Has risk management plan system influenced the speed of package insert revisions in Japan? [PDF]
Frontiers in MedicineIntroductionThe system of Risk Management Plan in Japan (J-RMP) is a relatively new system, implemented in 2013; thus, its effect on safety measures is still unclear.
Natsuko Kameyama +4 more
doaj +4 more sources
Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan [PDF]
Pharmacology Research & Perspectives, 2023 Recently, post‐marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems.
Rieko Saito, Seiko Miyazaki
doaj +2 more sources
Journal of the Formosan Medical Association, 2016 A risk management plan (RMP) was introduced to monitor the association between initiation of antitumor necrosis factor-α (anti-TNF-α) therapy and tuberculosis (TB) and viral hepatitis infections.
Meng-Ju Chan +6 more
doaj +3 more sources
Holistic Disaster Risk Evaluation for the Urban Risk Management Plan of Manizales, Colombia
International Journal of Disaster Risk Science, 2017 Disaster risk depends on both the physical vulnerability and a wide range of social, economic, and environmental aspects of a society. For a better risk understanding, a holistic or integrated perspective was considered when risk was assessed for the ...
Martha Liliana Carreño +5 more
doaj +3 more sources
Risk of plan management of the Chinese economy [PDF]
Ekonomski Signali, 2023 Based on official PRC statistics and analytical data obtained from modern scientific and public research, it follows that the so-called Chinese economic miracle has ended.
Skoropad Vladimir
doaj +1 more source
Effects of safety warnings and risk management plan for Thiazolidinediones in Taiwan. [PDF]
Pharmacoepidemiol Drug Saf, 2015 Hsu JC +10 more
europepmc +2 more sources
Human Vaccines & Immunotherapeutics, 2022 Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages.
Miguel Betancourt-Cravioto +4 more
doaj +1 more source
Methodological Approaches to Risk Management of Advanced Therapy Medicinal Products
Разработка и регистрация лекарственных средств, 2023 Introduction. Advanced therapy medicinal products (ATMPs) rely on recent advances in medical science, but alongside with potential benefits they may also bring safety concerns for patients. The inherent complexity of the ATMP production and use calls for
A. A. Taube, N. Yu. Velts
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Безопасность и риск фармакотерапии, 2023 The Council of the Eurasian Economic Commission published Decision No. 81 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” on 19 June 2022 and enacted it on 6 December 2022.
T. M. Bukatina, E. V. Shubnikova
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