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Responsibilities of Importers and Distributors

Responsibilities of Importers and Distributors

by elena@investinu.ie | Oct 12, 2021 | Acorn Regulatory News, Medical Devices

MDR 2017/745, which was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine the revised responsibilities of the importer and the distributor under the new regulation. What is an Importer under MDR 2017/745?...
Pharmacovigilance KPIs: How They Can Assist You

Pharmacovigilance KPIs: How They Can Assist You

by elena@investinu.ie | Sep 8, 2020 | Acorn Regulatory News, Pharmacovigilance

How important are pharmacovigilance KPIs in the effective management of a PV system?  We look at the issue and look at how to generate an effective evaluation of your pharmacovigilance system.  This article is an update to an article first written in 2017. We consider...
Pharmacovigilance of Medicines for Rare Diseases

Pharmacovigilance of Medicines for Rare Diseases

by elena@investinu.ie | Jun 29, 2020 | Acorn Regulatory News, Clinical & Medical, Pharmacovigilance

We look at the issue of pharmacovigilance for orphan or rare diseases.  Many issues associated with the sector are challenged by the small patient population. This article looks at the commonly used strategies for the evaluation of post-approval safety and the...
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