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 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.
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. […]
The art of working after Covid-19: a positive side effect from Covid-19 by Danilo Maruccia and Pierre Crivelli Last decade brought market evolution with itself, and a race for research and development to increase opportunities, optimize costs and improve efficiency in the way leaders do business and manage their companies. This heritage comes from 2008 […]
Fight against SARS-CoV-2: treatments and prevention. What are the pros and cons of drug therapies? by PQE Group’s Infodemic Research Team Topic: Science Researchers: Emanuele Volpe, Project Manager Valeria Famiglini, Consultant Abstract The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has recently emerged as the etiological agent of Coronavirus Disease 2019 (COVID-19), which causes serious […]
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 […]
Medical Cannabis: a fast-expanding market by Emanuele Bertea, Paola Cinquanta, Giampaolo Mazzuca Last year, the Cannabis global market has shown a rapid expansion. Canada was the first country to regulate its Medical Cannabis industry and market – meaning the production and commercialization of the plant and its derivatives – and now Europe is following Canada’s […]