by Nick | Apr 18, 2023 | Clinical Research, Pharmacovigilance
Welcome to the fascinating yet complex world of Pharmacovigilance (PV)! This field stands as an indispensable pillar in drug safety, ensuring the well-being of millions around the globe. However, the path is far from smooth; it’s full of unique challenges and...
by Nick | Apr 4, 2023 | Pharmacovigilance
Imagine a pharmaceutical company navigating the intricate labyrinth of drug development and patient safety. Amid these complexities, an intriguing solution has been emerging: pharmacovigilance outsourcing. This practice involves entrusting a part or the entirety of...
by Kamile Gruduls | Mar 9, 2023 | Announcement, Clinical Research, Medical Information, Pharmacovigilance, Regulatory Affairs
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new...
by Nick | Mar 7, 2023 | Clinical Research, Pharmacovigilance, Regulatory Affairs
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years...
by Nick | Jan 25, 2023 | Pharmacovigilance, Webinar
National Differences For Pharmacovigilance Requirements In Europe. Webinar date & time: March 7th 15:00 CET Join our webinar on “Navigating National Differences in Setting up a Pharmacovigilance System in Europe.” This session will discuss the...
by Nick | Jan 17, 2023 | Pharmacovigilance
Pharmacovigilance requirements in Europe are primarily governed by the European Medicines Agency (EMA) through the EU Regulation on Pharmacovigilance (Regulation (EU) No 1235/2010). However, some national differences in implementing and enforcing these requirements...