April 19, 2020
Introduction PSURs are pharmacovigilance documents that provide risk-benefit balance assessment. The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of […]
March 3, 2020
In Brief The new European Union (EU) post-market surveillance (PMS) plan would act as a detailed tool for benefit-risk evaluation for medical devices. If the […]
March 2, 2020
In Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical […]
February 18, 2020
In Brief For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant […]
February 11, 2020
In Brief Medicines and devices that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices […]
February 4, 2020
In Brief This particular write-up presents a background about e-dossiers that are submitted to regional authorities by pharmaceutical companies for drug registrations. The write-up highlights the […]
January 10, 2020
1.0 Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and could make a major impact on costs related […]
December 17, 2019
1.0 Background The implementation of the new medical device regulations (MDR) on 25th May, 2017 has presented medical device manufacturers with several drastic changes in the […]
