OPINION The mandatory adoption of ISO/ICH E2B(R3) in individual case safety reporting represents a pivotal shift in the pharmacovigilance landscape within the EU. This new standard not only seeks to…
OPINION The introduction of mandatory ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU marks a significant shift in pharmacovigilance practices. This evolution is critical as it aims to enhance…
OPINION The recent meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) underscores a pressing issue that plagues the healthcare industry: the shortage of essential…
OPINION The upcoming virtual training course on the EudraVigilance system highlights a crucial aspect of clinical trials that often goes overlooked: the need for comprehensive training for sponsors. As the…
OPINION The upcoming webinar hosted by the European Medicines Agency (EMA) on the new variations guidelines for marketing authorisation holders marks a significant step in the evolving landscape of healthcare…
OPINION The planned Q&A clinic by the European Medicines Agency regarding Product Management Service (PMS) interfaces marks a significant step toward enhancing the usability of medical products. With the shift…
OPINION The evolution of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) represents a significant milestone in the regulatory landscape of medicinal products. However, while the service aims to improve pharmacovigilance…
OPINION The upcoming clinic hosted by the European Medicines Agency presents a crucial opportunity for stakeholders in the healthcare sector to engage with the rapidly evolving landscape of Product Management…
OPINION In the ever-evolving landscape of healthcare, the significance of robust regulatory review practices cannot be overstated. As technology and medical devices advance at a rapid pace, the pre-market review…
OPINION The emergence of personalized medical devices (PMDs) signals a transformative shift in the healthcare landscape, where the focus is increasingly on individualized patient care. The unique characteristics of PMDs…