Why PV Mandates Matter in 2026? Pharma manufacturers are rapidly launching their products across borders, directly intensifying the burden on safety monitoring. On the other hand, to enable quick signal detection, the PV processes are
Read MoreDo you know? As per the EU Regulation 2025/1466 and evolving signal-monitoring expectations, accountability of the Qualified Person Responsible for Pharmacovigilance (QPPV) towards EudraVigilance monitoring, PSMF data accuracy, audit-readiness, etc., is becoming significant and mandatory.
Read MoreCan AI Replace Signal Detection? The simple answer we have is, not yet, and not entirely. For sure, Artificial Intelligence (AI) is, or will be, capable of rapid scanning of humongous Pharmacovigilance databases, including FAERS,
Read MoreDo you have authorization to conduct a clinical trial with your investigational drug? Do you know that you should evaluate the safety data and analyse the emerging risks during trials? During the clinical development of
Read More
EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation
Read More