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 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 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 […]
Covid-19 vaccines supply chain has become a target for cybersecurity attacks. How real is the threat? by Damiano Peruzzi – PQE Group Abstract In the constantly evolving scenario of Cybercrime, two main aspects reveal an increased urgency of tackling the challenges posed by Cyber Threats. The first is the fast scalability of cyber targets, which […]
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.
Data Privacy and Personal Freedom: How are they influenced by technology in the Pandemic situation? by PQE Group’s Infodemic Research Team Topic: Legal Researchers: Fabio Saragoni, Project Manager Marco Tordelli, Senior Consultant Different government approaches and their consequences Abstract Among the topics that most shook the public debate in the last months of pandemic, the […]
How the Covid-19 crisis differs from the economic crises in the past? by PQE Group’s Infodemic Research Team Topic: Social Economy Researchers: Ana Luisa Moreira, Consultant Abstract Humankind has experienced several difficult periods in recent history, some of which lead to an economic crisis. This study aims to compare two of the economic crises of […]
European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.
Nitrosamine Risk Assessment (Step 1): new deadlines for BIO and Chemical products announced by PQE Group As indicated in the latest updates on HMA.eu official website, the deadlines for Nitrosamine Risk Evaluation (STEP 1), formerly set on October 1st 2020 due to COVID-19 outbreak, have been newly updated as following: March 31st for Chemical medicines. […]
How Government Policies affect the number of COVID 19 infections worldwide? – a Case Study by PQE Group’s Infodemic Research Team Topic: Mathematical Models Researchers: Dario Garcea, Consultant Miguel Angel Andrade Moreno, Senior Consultant Different government approaches and their consequences Abstract The COVID 19 is a pandemic influencing the human health and economy at a […]