Con sesiones de gran interés para la globalización de productos sanitarios la Comisión Europea realizó está semana un despliegue como anfitrión de IMDRF en esta segunda sesión en Berlin. Se trataron : Productos a medida (versus personalizados), productos innovadores, Inteligencia Artificial (estado AIA, «lasaña legislativa», sandboxes para SaMD-AI), UDI (a nivel global y preocupación por la divergencia e.g. master-UDI), EUDAMEDs (cada area va a poner su base de datos …)
Os dejamos algunas fotos de las sesiones .. esta es la web
Andrzej Ryś Principal Scientific Adviser, Directorate-General for Health and Food Safety, European Commission
Nada Alkhayat Policy Officer, Directorate General for Health and Food Safety, European Commission
Jesús Rueda Rodríguez Director General Strategies, Special Projects and International Affairs, MedTech Europe
Leo Hovestadt EU Director Governmental Affairs, Elekta
Koen Cobbaert Senior Manager – Quality, Standards & Regulations, Philips
Mariana Madureira Senior Officer, Health Products Directorate, INFARMED
Augusto Bencke Geyer Head of Medical Devices Office, Brazilian Health Regulatory Agency
Yesica Anastasio Coordinator of the International Relations Program at the National Administration of Drugs, Food and Medical Devices (ANMAT)
Kenneth J. Cavanaugh Deputy Office Director, U.S. Food and Drug Administration
Tracey Duffy First Ass.Secretary of the Medical Devices Product Quality Div, TGA, Australia
Sally Prawdzik Acting Director, Policy and International Programs, Health Canada