Preparing for the EU HTA Regulation: A Practical Roadmap
The EU HTA Regulation is now live, and the Joint Clinical Assessment is reshaping how evidence is judged across Europe. The companies that prepare early[…]
Market Access for Biosimilars: Beyond the Price Tag
Biosimilars have saved European health systems tens of billions of euros — yet uptake remains uneven, and market access is about far more than offering[…]
Market Access for Rare Disease Therapies: Navigating Uncertainty
Rare disease therapies can transform lives — but getting them reimbursed is one of the hardest challenges in market access. Small populations, limited data and[…]
Signal Detection: Turning Safety Data into Action
Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central[…]
The EU QPPV: Your Single Point of Accountability for Drug Safety
Every company marketing medicines in the EU must have one person permanently responsible for the safety of those products: the Qualified Person for Pharmacovigilance. It[…]
The EU Joint Clinical Assessment: What It Means for Your Product
From January 2025, the way new medicines are clinically assessed in Europe changed. The Joint Clinical Assessment (JCA) introduces a single, EU-wide evaluation of clinical[…]
From Approval to Access: How Reimbursement Really Works in Greece
A marketing authorization lets you sell a medicine. Reimbursement is what lets patients actually receive it. In Greece, the two are separate processes — and[…]
Navigating EOF Marketing Authorizations: What Sponsors Need to Know
Bringing a medicine to the Greek market starts with a marketing authorization — but the route you choose, and how well your dossier is prepared,[…]