Tag: Health Policy

EMA seeks stakeholder input on new reflection paper to reduce and replace non‑human primate use in medicines safety testing through 3Rs approaches.
Three days in Brussels help advance the European Declaration on Rare and Complex Diseases
Inviting views on how a stronger EU disability strategy up to 2030 can support inclusive research, data sharing and innovation.
Gathering key stakeholders, including EU policymakers, industry leaders, patient advocacy groups, researchers, and healthcare providers. Its goal is to identify concrete actions and incentives to enhance innovation across the rare disease ecosystem.
EMA invites comments on new quality guideline for bacteriophage‑based medicines to support safe phage therapy development in Europe.
With over 300 million people affected by rare diseases, timely access to effective therapies is critical. Despite strong alignment in regulatory expectations, patients in many regions face years of delays highlighting the need for improved international coordination.
On November 12 at 11:00am (GMT+3) , IBG RareBoost will host Dr. Başak Uysal from the ERDERA Coordination Team. She will deliver a presentation titled “Accelerating Innovation Through Coordinated Research Platforms: The ERDERA Approach.”
New EMA ICH M14 guidelines sets common international standards for non‑interventional real‑world data studies to strengthen medicine safety assessment.
Sharing patient‑centred methods, early diagnostics, and data‑driven trial innovation to accelerate rare disease research across Europe.