National Scientific Advice Coordinator
Senior Assessor/Medicines Evaluation Department
INFARMED - National Authority of Medicines and Health Products, I.P. Portugal
Member of the Committee for Advanced Therapies and of the Biologics Working Party/CHMP - EMA
margarida.menezes@infarmed.pt

Margarida Menezes Ferreira graduated in Biology at the Faculty of Sciences of the University of Lisbon.

She had her PhD degree in Medical Biochemistry at the Aix-Marseille II University in France 1981 and did a post-graduate research in molecular endocrinology at the National Institutes of Health USA until 1984. She published several research papers in peer-reviewed journals amongst which two of them were selected for the Year Book of Endocrinology.

Since 1996 she is part of INFARMED, the Portuguese regulatory authority for medicines and health products having developed the strategic plan for the installation of the Biologics, Biotechnology and Microbiology Departments of the National Laboratory for the Control of Medicines and Health Products and coordinated its implementation and directed until 2001.

Since 1999 to the present she has been the INFARMED appointed member of 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 cell based therapies. Initially as guest member and since 2007 as a permanent member of the Cell based Products Working Party she has been in the construction of the regulatory framework and quality guidance for cell based medicinal products since the begining. Presently and since its start in 2009 she is member, initially as alternate, representing Portugal in the Committee for Advanced Therapies.

She also collaborates as guest professor with the Faculty of Pharmacy from the University of Lisbon coordinating a chair on Advanced Therapy Medicinal Products. She is also lecturing on Regulatory aspects related to Biotechnology and Advanced Therapy Medicinal Products in several post-graduate courses from Universities of Coimbra and Aveiro and at the Instituto Superior Técnico /University of Lisbon in the PhD program MIT-Portugal.

Since 1998 she is a member of the National Vaccination Commission; since 2004 she is Member of the Board of the Biotechnology College at the Biologists Association (Colégio de Biotecnologia da Ordem dos Biólogos).

October 2012