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 […]

PQE Group - Infodemic Project - How the COVID-19 crisis differs from the economic crisis in the past

How the Covid-19 crisis differs from the economic crises in the past?

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 […]

PQE Group - Infodemic Project - How Government Policies affect the number of COVID 19 infections worldwide

How Government Policies affect the number of COVID 19 infections worldwide? – a Case Study

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 […]