Paulo Pereira
Paulo Pereira, Ph.D., is a distinguished expert at in vitro diagnostic medical devices (IVD-MD), with an extensive career spanning various roles, including a current position at the European Medicines Agency (EMA) as an IVD-MD Expert since August 2020. He boasts a solid foundation in regulatory affairs, notably IVDR (RE (EU) 2017/746 and CE marking conformity assessment procedures. Dr. Pereira's skills encompass a wide range of competencies from biostatistics and project management to quality assurance and metrology, highlighting his analytical, and problem-solving capabilities. Dr.Pereira has held significant roles, including the R&D Head and Postdoc Researcher at the Portuguese Institute of Blood and Transplantation since June 2017, where he structured and led R&D projects, enhancing laboratory-developed tests (LDTs) and ensuring stringent quality control. In his capacity as a member of the Clinical and Standards Laboratory Institute (CLSI), he has played a pivotal role since January 1, 2024, as part of the Consensus Council. His involvement extends to active participation in Document Development Committees (DDCs) focused on pivotal areas such as the Establishment and Verification of Qualitative Test Performance (EP12), Accuracy Using ROC Curves (EP24), and Total Analytical Error (EP21/EP46). This role underscores his expertise in enhancing standards and protocols within the medical laboratory field, specifically focusing on quality control, accuracy, and the reliability of diagnostic tests. His contributions not only reflect his deep understanding of laboratory processes and quality assurance but also his commitment to advancing the field through developing guidelines that ensure high standards of practice and improved patient care outcomes globally. His academic contributions as a Quality Control Professor at the Lisbon School of Health Technology since October 2008, and his prolific writing, with over 35 peer-reviewed scientific and technical articles, position him as a leading authority in his field. Additionally, his experience as a Senior Auditor, with over 150 audits under his belt, demonstrates his comprehensive expertise in quality assurance, regulatory compliance, and metrology in the medical and IVD-MD sectors. Dr. Pereira holds a Doctor of Philosophy in Biotechnology with a specialization in Microbiology from the Catholic University of Portugal. This academic prowess is further supported by a Master of Science in Health Engineering and a background Bachelor of Science in Clinical Analysis and Public Health. In summary, Dr. Pereira's career is marked by his contributions to the field of medical diagnostics, regulatory expertise, research, and education, showcasing his role as a key figure in advancing quality assurance, regulatory compliance, and innovation in healthcare.