IVDR 746

EU IVDR – Clinical Evidence and Performance Evaluation

EU IVDR – Clinical Evidence and Performance Evaluation by Andrea Colombo, MD Compliance Expert – PQE Group The issues exposed in this article will be discussed in “In Vitro Diagnostic Medical Device Regulation 746/2017: what to know to be ready” free Webinar by PQE, on July 8th @11:30 a.m. CET – Register now to secure […]

ICSR pharmaco vigilance data challenges

ICSR and Pharmacovigilance Data: Challenges for Pharmaceutical companies

Pharmacovigilance Data: challenges for Pharmaceutical Companies by: Daniela Rota PV Unit Manager & GVP Compliance Advisor @ PQE Group Marianna Esposito GCP Unit Manager, GCP Advisor & Auditor @ PQE Group Francesco Abbate CSV/CSA & Data Integrity Advisor @ PQE Group Pharmaceutical companies are asked every day to collect pharmacovigilance data in a structured format […]

Critical Utilities GMP Compliance and new Annex 1

New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.

New EU GMP Annex 1: Implications for QRM application

New EU GMP Annex 1 – Implications for QRM application by Alessio Rosati Sterility Assurance Executive Consultant – PQE Group The issues exposed in this article will be discussed in “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20th@ 10 a.m. CET. Register now to secure your presence. Introduction After a […]

Smart Working: dealing with IT support implications

Smart Working: dealing with IT support implications by Dario Palese Current global health emergency situation is forcing the most of companies to maximize the smart working solution: In order to ensure the same performance whether working in the office or in smart working, IT services need to face this new reality. This means to refocus […]

Windows 7 to 10 migration strategy

How to deal with Windows end-of-life

We consider the potential risks for Pharma and MD companies keeping their systems running on obsolete Windows versions and a good strategy to get up to date.

Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers.