Enhancing Pharmacovigilance Practices: Insights from Audits and Ethical Connotations

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11240%2F24%3A10487000" target="_blank" >RIV/00216208:11240/24:10487000 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=jj5pTXkbqJ" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=jj5pTXkbqJ</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.36290/csf.2024.033" target="_blank" >10.36290/csf.2024.033</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Enhancing Pharmacovigilance Practices: Insights from Audits and Ethical Connotations

Popis výsledku v původním jazyce

Pharmacovigilance, pivotal in ensuring drug safety and regulatory compliance, requires meticulous surveillance and adherence to ethical standards. This article explores the multifaceted realm of pharmacovigilance, emphasizing the essential role of pharmacovigilance audits and compliance monitoring. By delving into key areas such as drug safety surveillance, signal detection, literature monitoring, and ethical considerations, this research sheds light on critical aspects of pharmacovigilance activities. The paper examines the outcomes of pharmacovigilance audits, highlighting common findings and areas for improvement to enhance regulatory compliance and the safety of pharmaceutical products. Insights gleaned from real-world experiences and regulatory guidelines underscore the importance of fostering a culture of good practice and ethical conduct in pharmacovigilance activities. By addressing challenges and trends, and elucidating the critical interaction between regulatory compliance, signal detection, and ethical considerations, this article provides valuable insights for stakeholders in the pharmaceutical industry, aiding them in optimizing pharmacovigilance systems and safeguarding patient safety.

Název v anglickém jazyce

Enhancing Pharmacovigilance Practices: Insights from Audits and Ethical Connotations

Popis výsledku anglicky

Pharmacovigilance, pivotal in ensuring drug safety and regulatory compliance, requires meticulous surveillance and adherence to ethical standards. This article explores the multifaceted realm of pharmacovigilance, emphasizing the essential role of pharmacovigilance audits and compliance monitoring. By delving into key areas such as drug safety surveillance, signal detection, literature monitoring, and ethical considerations, this research sheds light on critical aspects of pharmacovigilance activities. The paper examines the outcomes of pharmacovigilance audits, highlighting common findings and areas for improvement to enhance regulatory compliance and the safety of pharmaceutical products. Insights gleaned from real-world experiences and regulatory guidelines underscore the importance of fostering a culture of good practice and ethical conduct in pharmacovigilance activities. By addressing challenges and trends, and elucidating the critical interaction between regulatory compliance, signal detection, and ethical considerations, this article provides valuable insights for stakeholders in the pharmaceutical industry, aiding them in optimizing pharmacovigilance systems and safeguarding patient safety.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

30311 - Medical ethics

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Česká a slovenská farmacie

ISSN

1210-7816

e-ISSN

1805-4439

Svazek periodika

73

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

10

Strana od-do

13-22

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85218621877