The Necessity of Harmonizing Adverse Event Terminology in Medical Device Reporting — 2025-12-03 01:06
OPINION The ongoing challenges surrounding adverse event reporting in the medical device sector highlight a critical need for standardized terminology. Currently, the fragmented nature of language used across various reporting…
The Implications of GHWP’s Voluntary Withdrawal from IMDRF — 2025-12-03 01:06
OPINION The recent voluntary withdrawal of the Global Harmonization Working Party (GHWP) from the International Medical Device Regulators Forum (IMDRF) raises significant questions about the future of global regulatory harmonization…
The Necessity of User-Friendly Training in Regulatory Submissions
OPINION In an increasingly complex regulatory landscape, the importance of user-friendly training cannot be overstated. The upcoming PMS Product User Interface (PUI) training offers a timely opportunity for stakeholders to…
Navigating the Challenges of Medicinal Product Shortages
OPINION The increasing frequency of medicinal product shortages presents a significant challenge to healthcare systems globally. The upcoming meeting of the Executive Steering Group on Shortages and Safety of Medicinal…
The Importance of Consumer Advocacy in Pharma Regulation
OPINION The recent bilateral meeting between the European Medicines Agency (EMA) and the European Consumer Organisation (BEUC) underscores a pivotal shift in the pharmaceutical regulatory landscape. As consumer advocacy gains…
The Importance of Big Data in Veterinary Medicine
OPINION The Fifth Veterinary Big Data Stakeholder Forum highlights a critical juncture in veterinary medicine where data analytics is becoming increasingly pivotal. In an age where information drives decision-making, the…
The Importance of Non-Clinical Data in Regulatory Decision-Making — 2025-12-03 01:04
OPINION The role of non-clinical data in the regulatory landscape is often underestimated, particularly in the context of medical countermeasures. This upcoming workshop by the European Medicines Agency (EMA) highlights…
The Challenges of Addressing Medicine Shortages: A Call for Transparency and Innovation
OPINION Medicine shortages pose a significant challenge to healthcare systems across Europe and beyond. The upcoming EMA public webinar represents a proactive step towards addressing this urgent issue by putting…
The Critical Role of External Controls in Regulatory Frameworks
OPINION The upcoming workshop by the European Medicines Agency on the use of external controls for evidence generation highlights a pivotal shift in the regulatory landscape. Traditionally, regulatory decision-making has…
The Importance of Collaborative Platforms in Cancer Treatment Optimization
OPINION The upcoming EMA Cancer Medicines Forum (CMF) exemplifies the critical need for collaboration among industry stakeholders in the realm of cancer treatment optimization. As cancer continues to be a…