Zobrazeno 1 - 10
of 172
pro vyhledávání: '"pharmacovigilance system"'
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 3, Pp 331-340 (2024)
INTRODUCTION. Documents on the pharmacovigilance system of the marketing authorisation holder (MAH), including the Pharmacovigilance System Master File (PSMF) and the PSMF-based summary of the pharmacovigilance system (SPS), are a mandatory component
Externí odkaz:
https://doaj.org/article/425b4e69f60547eabdb9f68f05519747
Autor:
Juan Granja López, Carlos Estebas Armas, Manuel Lorenzo Dieguez, Inmaculada Puertas Muñoz, Elena De Celis Ruiz, Ricardo Rigual, Mireya Fernández-Fournier, Gabriel Torres Iglesias, Sara Sánchez Velasco, Antonio Tallón Barranco, Olga Rogozina, Elena Ramírez, Miguel González-Muñoz, Laura Lacruz Ballester
Publikováno v:
Frontiers in Pharmacology, Vol 15 (2024)
Objectives: To know the frequency and characteristics of neurological manifestations of probable immune origin occurring after exposure to COVID-19 vaccination. In addition, to pre-study the usefulness of the Spanish pharmacovigilance system and lymp
Externí odkaz:
https://doaj.org/article/c537f0d6be5c456e9d52696d1a373ecc
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 22-29 (2023)
The development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first ado
Externí odkaz:
https://doaj.org/article/8685ecadd6b14595844ddc25f7bbee54
Publikováno v:
Current Issues in Pharmacy and Medical Sciences, Vol 36, Iss 2, Pp 103-107 (2023)
Introduction. The use of medicines involves trade-offs between their therapeutic benefits and inherent risks. Several studies show that numerous adverse drug reactions (ADRs) could be avoided by increasing patients’ awareness of medicine’s risks.
Externí odkaz:
https://doaj.org/article/adf1362b3a6747a88f4481efbfc622a1
Publikováno v:
Безопасность и риск фармакотерапии, Vol 9, Iss 4, Pp 185-190 (2021)
Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacov
Externí odkaz:
https://doaj.org/article/024e9db267684f748cdb8e2cc3a7f0c5
Publikováno v:
Frontiers in Pharmacology, Vol 14 (2023)
Objective: This study aimed to develop active surveillance programs (ASPs) for anaphylaxis using the China Hospital Pharmacovigilance System (CHPS) and analyze the characteristics, allergens, and management strategies for anaphylaxis within a tertiar
Externí odkaz:
https://doaj.org/article/489207b11ccd491dbced7cd64357054d
Publikováno v:
Безопасность и риск фармакотерапии, Vol 10, Iss 1, Pp 13-18 (2022)
The inspection of pharmacovigilance systems is regulated by the Good Pharmacovigilance Practices (GVP) and local laws and regulations. Inspections may be carried out by audit teams of competent authorities as part of regulatory activities or business
Externí odkaz:
https://doaj.org/article/e95c45c62f6c44d9a551c2829bcd6bc2
Autor:
Nataliya Stepanyuk, Oleg Pinyazhko, Tetiana Poshivak, Tetiana Bessarab, Oksana Parfenyuk, Yuriy Sagach
Publikováno v:
Acta Medica Leopoliensia, Vol 27, Iss 3-4, Pp 143-149 (2021)
Aim. The paper aims at conducting the analysis of the reported adverse reactions and poor efficacy of medicines registered by the doctors of Lviv city and region in 2018-2020. Materials and Methods. The object of our study were the reports receive
Externí odkaz:
https://doaj.org/article/c347651d172c40398d6202d5fea13710
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Akademický článek
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