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 […]

Covid Vaccine Technology Transfer: 5 reasons, risks, good practices

Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.
In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.

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 […]

GDPR: 3 years later What we learned and what we need to know about (whitepaper)

GDPR: 3 years later What we learned and what we need to know about by PQE Group The General Data Protection Regulation (GDPR) of the European Union entered into force on 25 May 2018. It has been three years since the GDPR came into force, and during that time, we have seen more published EU-wide guidelines […]

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.

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group As EU MDR 2017-745 Regulation deadline is approaching, cybersecurity for Medical Devices has become a main concern for all Networked Medical Devices manufacturing companies. In the video below, we’ll review the most important requirements […]

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 […]

A snapshot of serialization . PQE Group Insights - Pharmaceutical

A snapshot of Serialization in Pharmaceutical Industry

A snapshot of Serialization in Pharmaceutical Industry. by Danilo Neri, PQE Group VP Operations & Partner Most of the regulated agencies have established serialization and aggregation in order to fight counterfeiting and to enhance the level of control of the entire supply chain related to pharmaceutical Products.