Quality-Management-Systems-in-Pharmacovigilance

Quality Management Systems in Pharmacovigilance: Upholding Drug Safety Excellence

ByNiamh

Pharmacovigilance is a crucial pillar in the pharmaceutical industry, encompassing the detection, assessment, understanding, and prevention of adverse effects and other drug-related issues. This article delves into the intricacies of establishing and maintaining a robust Quality Management System (QMS) tailored to pharmacovigilance requirements. Drawing insights from regulatory guidelines and industry standards, we aim to provide…

Vietnams-Pharmaceutical-Industry
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Vietnam’s Pharmaceutical Industry: Current Landscape and Future Outlook

ByNiamh

The pharmaceutical sector in Vietnam has witnessed substantial growth and transformations in the past two decades. Government health policies have played a pivotal role in accelerating the development of Vietnam’s pharmaceutical industry, leading to a significant increase in its market size—from USD 5.4 billion in 2018 to an estimated USD 6.5 billion in 2021. According…

Digital-Health-Technologies
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Digital Health Technologies – Revolutionizing Healthcare

ByNiamh

In a world where technology is advancing at an unprecedented pace, the integration of digital health technologies into the healthcare landscape has become increasingly vital. Recognizing the significance of this convergence, the U.S. Food and Drug Administration (FDA) has taken a significant step forward this month (October 2023) by establishing a new Advisory Committee on…

commissioning-and-qualification-storage

Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

ByNiamh

What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…