Enrolment closed

Master in
Quality, Regulatory, Clinical & Medical Affairs in Medical Devices & In Vitro Diagnostics

1st Edition

Management

  • Oriol Vidal Fàbrega

    Professor of Genetics at the University of Girona, PhD in Genetics specialised in animal science, including the design of molecular diagnostics protocols, genotyping methods and the discovery of new molecular markers. His latest research is focused on the process of scientific discovery, its development and its social impact.

Coordination

  • Josep Pareja Gómez

    Biochemist, PhD in Biomedicine specialised in molecular biology. Professional with more than ten years’ experience in the In Vitro Diagnostics (IVD) industry in the fields of R&D, Clinical Affairs, Regulatory Affairs and Medical Affairs, as well as in the implementation of QMS under ISO 13485 in start-ups (Stat-Dx, Sense Biodetection) and multinational companies (QIAGEN). Specialised in the conceptualisation and implementation of regulatory-clinical strategy up to regulatory approval (FDA and notified bodies). Experience in planning post-market surveillance strategies and monitoring plans for marketed products. Currently Director of Clinical Sciences at Sense Biodetection.

    Linkedin

Teaching staff

  • Marta Bas

    Biologist, specialized in R&D and Quality Quality control. Professional with more than 10 years experience in  R&D (Applus, QIAGEN) and Quality Control in Medical Devices and IVD industry. Currently QC Senior Manager at QIAGEN.

    Linkedin

  • Claudia Ben Dov

    Biologist, PhD in Molecular Biology with +10 years of proficiency in start-ups and international companies of In Vitro Diagnostics (IVD) Industry  (Stat-Dx, QIAGEN and The Binding Site).
    Experienced from concept throughout the entire life cycle of the products in  R&D, Operations, Regulatory Affairs, and Business strategy areas. Currently, Business Strategy Manager of Medical devices division & consultant at Ambit-BST.

    Linkedin

  • Pau Boher

    Biologist, PhD in Cell Biology. Professional with more than five years’ experience in R&D and Clinical Affairs in the IVD industry. Currently Clinical Study Lead at QIAGEN.

    Linkedin

  • Pierre-Antoine Deglesne

    PhD in Immunology and Cancer (Paris XI, France). Teacher at Master of Immunology program at the IVIC Institute in Venezuela and experienced as Clinical Research Associate (CRA). With 9 years of experience  in the Medical Devices Industry, he led the research and development  of  class II and class III medical devices, and also participated in operations within the IVD industry. Currently, senior consultant at  AMBIT-BST, specialized in software as a medical device under MDR, Internal Audits ISO13485 and training for IVD and MD companies.

    Linkedin

  • Martí Juanola

    Biologist, PhD in Metabolomics. Professional with more than five years’ experience in R&D and Medical Affairs in the IVD industry. Currently Associate Director of Medical Affairs at QIAGEN.

    Linkedin

  • Alberto Molinero

    Biologist, specialised in Quality and Regulatory Affairs. Professional with more than 20 years’ experience in QA and RA in the Medical Devices (Cytognos and i-Line Biosystems) and IVD industry (QIAGEN). Currently Director of Quality Assurance at QIAGEN.

    Linkedin

  • Josep Pareja Gómez

    Biochemist, PhD in Biomedicine specialised in molecular biology. Professional with more than ten years’ experience in the In Vitro Diagnostics (IVD) industry in the fields of R&D, Clinical Affairs, Regulatory Affairs and Medical Affairs, as well as in the implementation of QMS under ISO 13485 in start-ups (Stat-Dx, Sense Biodetection) and multinational companies (QIAGEN). Specialised in the conceptualisation and implementation of regulatory-clinical strategy up to regulatory approval (FDA and notified bodies). Experience in planning post-market surveillance strategies and monitoring plans for marketed products. Currently Director of Clinical Sciences at Sense Biodetection.

    Linkedin

  • Luis Peñarrubia

    Biologist and Biochemist (UdG), PhD in Genetics (UdG). Professional with 10+ years experience in R&D in the IVD industry. Currrently Senior R&D lead at QIAGEN Barcelona. 

    Linkedin

  • Ester Sala

    Biologist, PhD in Immunology. Professional with ten years’ experience in R&D and Medical affairs in the IVD industry (STAT-Dx, QIAGEN). Currently Senior Medical Advisor at QIAGEN.

    Linkedin?

  • Oriol Vidal Fàbrega

    Professor of Genetics at the University of Girona, PhD in Genetics specialised in animal science, including the design of molecular diagnostics protocols, genotyping methods and the discovery of new molecular markers. His latest research is focused on the process of scientific discovery, its development and its social impact.

*Management reserves the right to modify the teaching staff, if necessary, to ensure the levels of quality and professional category.
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