A Bird Eye View On Pharmacovigilance And Quality Assurance

Pharmacovigilance and Quality Assurance (QA) are essential fields in pharmaceuticals dedicated to maintaining drug safety, efficacy, and regulatory compliance throughout a product's lifecycle. Pharmacovigilance emphasizes continuous monitoring, identification, and management of adverse drug reactions (ADRs), incorporating processes such as signal detection, causality assessment, and risk management to safeguard patient safety. QA complements these efforts by enforcing high standards in drug development and manufacturing through Good Manufacturing Practices (GMP), consistent quality checks, and compliance with regulatory standards. Emerging technologies, including artificial intelligence, machine learning, and blockchain, is enhancing the efficiency of adverse event detection and data integrity, while global harmonization efforts seek to unify regulatory frameworks for greater consistency across regions. Together, these fields address the complexities of modern drug development, such as personalized medicine and biologic therapies, supporting proactive risk management and fostering public trust in pharmaceuticals. This review highlights the integrated role of pharmacovigilance and QA in promoting safe, effective, and high-quality drug use, with a forward-looking perspective on digital transformation and global collaboration in advancing patient care.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-11-02
DOI
https://doi.org/10.5281/zenodo.14029139
Primary Topic
Animal Ecology and Behavior Studies
Type
article
Field-Weighted Citation Impact
0.00
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article

A Bird Eye View On Pharmacovigilance And Quality Assurance

Zenodo (CERN European Organization for Nuclear Research)
Animal Ecology and Behavior Studies
article

A Bird Eye View On Pharmacovigilance And Quality Assurance

article en

Abstract

Pharmacovigilance and Quality Assurance (QA) are essential fields in pharmaceuticals dedicated to maintaining drug safety, efficacy, and regulatory compliance throughout a product's lifecycle. Pharmacovigilance emphasizes continuous monitoring, identification, and management of adverse drug reactions (ADRs), incorporating processes such as signal detection, causality assessment, and risk management to safeguard patient safety. QA complements these efforts by enforcing high standards in drug development and manufacturing through Good Manufacturing Practices (GMP), consistent quality checks, and compliance with regulatory standards. Emerging technologies, including artificial intelligence, machine learning, and blockchain, is enhancing the efficiency of adverse event detection and data integrity, while global harmonization efforts seek to unify regulatory frameworks for greater consistency across regions. Together, these fields address the complexities of modern drug development, such as personalized medicine and biologic therapies, supporting proactive risk management and fostering public trust in pharmaceuticals. This review highlights the integrated role of pharmacovigilance and QA in promoting safe, effective, and high-quality drug use, with a forward-looking perspective on digital transformation and global collaboration in advancing patient care.

Zenodo (CERN European Organization for Nuclear Research)
Partnerships for the goals
Openalex Percentile: Top 56%
Animal Ecology and Behavior Studies
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A Bird Eye View On Pharmacovigilance And Quality Assurance · Zenodo (CERN European Organization for Nuclear Research) (2024) | TGRS Research Map | TGRS