European regulator’s perspective: best practice & future directions in cell therapy CMC

MARGARIDA MENEZES FERREIRA graduated in Biology at the Faculty of Sciences of the University of Lisbon. She did her PhD in Medical Biochemistry at the Aix-Marseille II University in France in 1981 and did postgraduate research in molecular endocrinology at the National Institutes of Health, USA, until 1984. She published several research papers in peer-reviewed journals. She has worked at INFARMED since January 1996, the Portuguese Regulatory Authority for Medicines and Health Products developing and supervising the installation of the Biologics, Biotechnology and Microbiology Departments for the National Laboratory for the Control of Medicines and Health Products and coordinating its implementation until 2001. From 1999 to 2001 she also directed the National Control Laboratory for Medicines and Heath Products (OMCL). Since 1999 she has been an appointed member for the Biologics Working Party at the European Medicines Agency (EMA). She has participated in the drafting of European guidance and scientific advice on biological medicinal products including biotechnological and biosimilars as well as gene- and cell-based therapies. She was member of the Cell Products Working Party until its closure and participated intensely in the construction of the regulatory framework and quality guidance for cell based medicinal products. Since 2009 she has been the Portuguese member at the Committee for Advanced Therapies. She lectures on regulatory framework for Biotechnology and Advanced Therapy Medicinal Products at the Faculty of Pharmacy from the University of Lisbon and in several postgraduate courses at the University of Coimbra and University of Aveiro as well as at the Instituto Superior Técnico /University of Lisbon and at the PhD program MIT-Portugal and Harvard-Portugal. She acted as a consultant expert for the building analytical capacity for laboratory control in the pharmaceutical sector in 2001 at Cape Verde for the World Bank and in 2005 at Angola with the European Commission. Since 1998 she has been a member of the National Vaccination Commission.

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