The Impact of ISO/ICH E2B(R3) on Pharmacovigilance Training
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…
The Future of Pharmacovigilance Training in the EU: Embracing ISO/ICH E2B(R3)
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…
Navigating the Challenges of Medicinal Product Shortages — 2025-12-11 19:41
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…
The Importance of Training in EudraVigilance for Clinical Trials
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…
Navigating the Future: The Importance of Understanding New Variations Guidelines
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…
The Implications of the Upcoming Q&A Clinic on Product Management Service Interfaces
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…
Navigating the Complexities of XEVMPD: A Critical Examination
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…
Navigating the Future of Product Management Interfaces in Healthcare
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…
The Importance of Robust Regulatory Review Practices in Healthcare
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…
The Future of Personalized Medical Devices: Navigating the Regulatory Landscape
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…