Latest Updates from EMA and EC regarding Signal Detection Process Signal Detection in Pharmacovigilance is a set of activities that aim to search for and identify safety signals from a wide variety of data sources. This process wants to determine whether there are new...
“When I was in my third grade of primary school, I read Madame Curie’s biography and that book really inspired me. Even though I was eight years of age, I found the scientific research very stimulating and exciting. That is what I owe my endless curiosity and passion...
Remote GVP Audit is a trend that is gaining traction rapidly. The COVID-19 pandemic has brought considerable changes in the management processes of several companies. This crisis has changed the way Life Sciences companies approach the GVP audits and forced them to...
Medical Device Regulation: what is it about? The EU’s Medical Device Regulation (MDR) is a hot topic in healthcare since it was officially published on 5th May 2017 and came into effect on 25 May 2017. The MDR replaces the EU Medical Device Directive (93/42/EEC) and...
In this blog article, we are answering questions received during the Q&A session of our webinar “PSUR under the Medical Device Regulation: Practical Guide”.
Preparation of the Periodic Safety Update Report (PSUR) is one of the new requirements introduced with the Medical Device Regulation (MDR). Although it shares the name with the well-known periodic safety report for medicinal products, its format and content are...
Regulation (EU) 2017/745 also known as the MDR, applicable since May 26th 2021, introduced a new obligation for the medical device manufacturers – according to the Article 86, they are obliged to prepare the medical device Periodic Safety Update Report (PSUR) for...
From on-site audits to remote audits The global spread of COVID-19 amongst other challenges has resulted in travel and work restrictions. This crisis has changed the way Life Sciences companies approach the GxP audits and forced them to look for new solutions that...
