On 28th April, the Basque Health Cluster started the “Expert on Regulatory Affairs” course which aims to provide professionals in the field of bio-health with the knowledge, skills and competences necessary to adapt to the new regulations of both the MDR and the IVDR. The course, which consists of 8 modules, is divided into 3 parts: before the summer, after the summer and early 2023.
Last week, on 24 June, the second module, and thus the first part, was completed. After a summer break, the third module will start on 9 September. This second part will include the modules on “Design, development and production”, “Usability Evaluation”, “Clinical evaluation” and “Clinical trial management”.
The lecturers for modules 3, 4, 5 and 6 are the following:
- Miguel Angel Campanero (A3Z Advanced)
- Begoña Alonso Gómez (BEALIA Servicios Técnicos y de Consultoría, S.L.)
- Rocío Díaz (Quirón)
- Isabel Gil (Navarrabiomed, Centro de Investigación Biomédica)
- Jon Mabe (Tekniker)
- Digna González(Bexen Cardio)
- Silvia Almaraz (Bexen Cardio)
- María Paños Correas (Allergan)
- Concepción Rodríguez (Agencia Española de Medicamentos y Productos Sanitarios)
- Ana Mª Villarta Aguilera (Agencia Española de Medicamentos y Productos Sanitarios)
- Gloria Hernández (Agencia Española de Medicamentos y Productos Sanitarios)
- Silvia Martín (Agencia Española de Medicamentos y Productos Sanitarios)
The course follows the combined methodology of theory and practice through lectures and group workshops. Classes will be held on Fridays, from 09:30 to 13:30, at BIC Bizkaia: Camino Astondo, Edificio 612, 48160 Derio, Parque Científico y Tecnológico de Vizcaya.
For more information and to download the program (in Spanish) click on the following button: