Greetings from TOPRA
We attended the TOPRA Annual Symposium in October in Berlin. TOPRA is the professional membership organisation for individuals who work in healthcare regulatory affairs across Europe.
At the symposium, many important topics were on the table. In the regulatory field, discussion topics included challenges associated Drug/Device combinations, patient self-medication, and constant improvement on different levels of the EU procedures (CP, MRP and DCP). In addition, the latest updates regarding the new Clinical Trials Regulation and Veterinary Regulatory environment were explored.
Improving Pharmacovigilance in all these fields is a constant concern. A major topic with growing importance for the future was bridging the gap between scientific/regulatory and HTA advice to ensure the best possible outcome in both fields.