Postmarketing vigilance system for medical devices in India is not as vigorous as of drugs. W
Materiovigilance involves post marketing surveillance of adverse events caused by medical …

Biologic-based medicines are used to treat a variety of diseases and account for around one-
quarter of the worldwide pharmaceutical market. The use of biologic medications among …

In order to explore the occurrence and development law of mining safety production
accidents, analyze its future change trends, and aim at the ambiguity, non-stationarity, and …

Introduction Medical devices play a crucial role in healthcare, addressing the diagnosis,
treatment, and monitoring of various medical conditions. This study conducts a …

Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as
pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) …

Background Medical devices play a crucial role in patient care but entail inherent risks,
necessitating the presence of Materiovigilance to monitor and prevent medical device …

Amidst rapid advancements in Artificial Intelligence and Machine Learning-enabled medical
devices (AI/ML-MD), this article investigates the regulatory challenges highlighted in the …

Biologic-based medicines are used to treat a variety of diseases and account for around one-
quarter of the worldwide pharmaceutical market. The use of biologic medications among …

The fundamental principle in any drug approval process is that the drug's perceived benefits
outweigh the risks at the population level. However, post-marketing authorization, adverse …

Pharmacovigilance (PV) is a discipline involved in identifying, assessing, and monitoring
adverse drug reactions to ensure the safety of patients. This chapter provides an overview of …