OPINION The upcoming HMA/EMA multi-stakeholder workshop on artificial intelligence represents a pivotal moment in the intersection of technology and regulatory frameworks within healthcare. As AI continues to evolve, it becomes…
OPINION The landscape of Software as a Medical Device (SaMD) is rapidly evolving, and the upcoming consultation set to close on December 8, 2025, represents a critical juncture for the…
OPINION The upcoming multistakeholder workshop on Patient Registries for Alzheimer’s disease represents a pivotal moment in the ongoing fight against this debilitating condition. As the landscape of Alzheimer’s research evolves,…
OPINION The European Medicines Agency’s (EMA) Quarterly System Demo scheduled for December 16, 2025, signifies a pivotal moment for digital health stakeholders, particularly as the industry continues to evolve in…
OPINION The Cancer Medicines Forum scheduled for September 2025 represents a pivotal moment for the healthcare community, especially in the field of oncology. As cancer treatment continues to evolve, the…
OPINION The upcoming EMA workshop focused on immunoglobulins presents a crucial opportunity for stakeholders to engage in a dialogue about the multifaceted challenges in drug development and regulation. Immunoglobulins play…
OPINION The upcoming DARWIN EU Advisory Board meeting represents a significant opportunity for stakeholders in the pharmaceutical industry to engage with regulatory bodies. However, the efficacy of such meetings hinges…
OPINION The upcoming DARWIN EU Advisory Board meeting scheduled for January 20, 2025, represents a pivotal moment for digital health regulation in Europe. With the digital health landscape evolving rapidly,…
OPINION The upcoming 15th Industry Standing Group (ISG) meeting highlights a significant shift in how the pharmaceutical and medical device industries engage with regulatory bodies. The decision to hold this…
OPINION The upcoming Seventh European Medicines Agency – EuropaBio bilateral meeting represents a crucial junction in the intersection between regulatory frameworks and biotechnological innovation. As the landscape of drug development…