Zobrazeno 1 - 10
of 2 825
pro vyhledávání: '"risk management plan"'
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
IntroductionThe 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. One of the purposes of J-RMP is to enhance the postmarketing safety measures to be
Externí odkaz:
https://doaj.org/article/44a0b3e42aad4d43b9faac9910e32f22
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 2, Pp 201-213 (2024)
INTRODUCTION. A risk management plan (RMP) is an important document for assessing and managing risks when using a medicinal product. An RMP is provided as part of the marketing authorisation application for a medicinal product. The requirements for t
Externí odkaz:
https://doaj.org/article/02c1e5f5d6ee40a99d9ef960cf955453
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
IntroductionIn Japan, drugs approved after the 2013 implementation of the risk management plan (RMP) have the opportunity to be evaluated for RMP termination. However, the guidelines for risk management following the termination of an RMP remain uncl
Externí odkaz:
https://doaj.org/article/5a330f6c0121448aa5779edca9b58680
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 4, Pp 463-472 (2023)
Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance document
Externí odkaz:
https://doaj.org/article/e8004f3c093145b6b68709628882ed19
Autor:
A. A. Taube, N. Yu. Velts
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 12, Iss 3, Pp 250-259 (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
Externí odkaz:
https://doaj.org/article/0d8d9aa87d7f4bef83d53ca800250e46
Publikováno v:
Saudi Pharmaceutical Journal, Vol 32, Iss 3, Pp 101963- (2024)
Background: Risk minimization measures (RMMs) are interventions intended to mitigate or prevent the occurrence of adverse reactions associated with medications. Having consistent measures across regulatory bodies (i.e., the Saudi Food and Drug Author
Externí odkaz:
https://doaj.org/article/9cf757b3ae0f499386fca331a078cebe
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 30-37 (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. A risk management plan (RM
Externí odkaz:
https://doaj.org/article/d4c7ef2297034442b9c3ec0d9c4a8568
Publikováno v:
BMC Health Services Research, Vol 22, Iss 1, Pp 1-12 (2022)
Abstract Background Risk management in the post-marketing phase is crucial to minimize health problems caused by drugs. Because ethnic factors may affect drug safety, the objective of this study was to explore concrete approaches to reflecting ethnic
Externí odkaz:
https://doaj.org/article/5be49a326057481f8e135c32a5d1ecab
Autor:
Rieko Saito, Seiko Miyazaki
Publikováno v:
Pharmacology Research & Perspectives, Vol 11, Iss 4, Pp n/a-n/a (2023)
Abstract 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. Pharmacists are expected to play an active role in ensuring the
Externí odkaz:
https://doaj.org/article/1e1d273e84014155bc4a942a3909f1d0
Autor:
Suzan Esslinger, Linda Quinn, Sami Sampat, Marijo Otero-Lobato, Wim Noël, Anja Geldhof, Nicole Herijgers, Sarah-Jane Reeder
Publikováno v:
Journal of Pharmaceutical Health Care and Sciences, Vol 8, Iss 1, Pp 1-15 (2022)
Abstract Introduction In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketi
Externí odkaz:
https://doaj.org/article/1dfec1e1580b49d5ab6ef74bb17fea62