Following the success of the “Expert Course in Regulatory Affairs 2022-2023” regarding the new Regulations on medical devices (MP) and in vitro diagnostic (IVD) medical devices under the new European Regulations (EU) 2017/745 and 2017/746 of the European Parliament and of the Council of 5 April 2017 on this type of products, the Basque Health Cluster is launching the second edition of the same. However, this second edition, “Expert Course in Regulatory 2.0”, is full of novelties!
Unlike the previous course, this is a practice-oriented course; it consists of 27 lessons, of which 20 are workshops with the aim of putting students to work. The remaining 7 are theoretical classes focused on providing basic theoretical knowledge to people who are not familiar with the regulatory framework applicable to MD and IVD products.
It has been incorporated a specific module on the procedure for obtaining FDA certification and access to the US market, also offering a workshop with real company experiences.
In addition, it has a panel of the best experts in the field, in which the following stand out: Agencia Española de medicamentos y Productos Sanitarios (AEMPS), Centro Nacional de Certificación de Productos Sanitarios (CNCPS) and Federación Española de Tecnología Sanitaria (FENIN). Nevertheless, we do have outstanding and/or distinguished entities in the community such as A3Z analytical consulting services, ALLERGAN, AJL OPHTHALMIC, BEALIA servicios técnicos y de consultoría, BEXEN CARDIO, BEXEN MEDICAL, Instituto sanitario de investigación BIOARABA, BIOLAN HEALTH, CINFA, NARU INTELLIGENCE and TEKNIKER.
For more information about the course, registration options and fees, download the programme by clicking the button below:
AEMPS y CNCPS:
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- Gloria Hernandez, Head of ON (CNCPS)
- Silvia Martin, Auditor and product reviewer (CNCPS)
- Julia Caro, Head of Area ON 0318 (CNCPS)
- Concepción Rodriguez, Head of Clinical Research Area (AEMPS)
FENIN:
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- Maria Alaez, Technical Director for Regulatory Affairs
A3Z:
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- Miguel Ángel Campanero, A3Z´s CEO
ALLERGAN:
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- María Paños , Medical device Quality & regulatory senior speacialist
AJL OPHTHALMIC:
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- Eva Larra, Director of Regulatory Affairs and New Product
BEALIA:
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- Begoña Alonso, Bealia´s CEO
BEXEN CARDIO:
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- Digna Gonzalez, R+D+i Director
- Silvia Almaraz, Product Manager
A:BEXEN MEDICAL:
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- Gorka Ramirez, Technical Pharmaceutical Director, (Design, Development, Clinical Trials, Regulatory, Quality Control)
BIOARABA:
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- Maria Cabero, Clinical Study Manager en la unidad de ensayos clínicos
- Zuriñe Abajo, Project Manager
BIOLAN HEALTH:
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- Larraitz Añorga, Chief Executive Officer
CINFA:
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- Maria Güemes, Regulatory Advisor in the consumer healthcare scientific department
- Francisco Moleres , Scientific and regulatory advisor
NARU INTELLIGENCE:
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- Ainhoa Ariceta, Head of Regulatory Affairs and Quality Management
- Maddi Agirre, Regulatory Affairs technician
TEKNIKER:
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- Jon Mabe, Bussiness Director
- Nerea Arandia, Director of the Electronics and Communications Unit
*The teaching staff has not yet been fully established, and more specialists in the field of the regulation of the different types of medical devices will be joining in the near future.
