Margarida Menezes Ferreira

Margarida Menezes Ferreira is a biologist by training, PhD in Medical Biochemistry

(Université d’ Aix-Marseille II in France) and has a post-graduate fellowship at the National

Institutes of Health, NIH, USA. Her research focused on molecular endocrinology. She has been guest

professor at Lisbon and Coimbra Universities.

Margarida worked for 23 years as researcher at INFARMED - National Authority of Medicines and

Health Products, Portugal, having developed, and coordinated the Biological Laboratory of the

National Control Laboratory for Medicines and Heath Products (OMCL).

She was also senior CMC assessor and Scientific advice coordinator.

She represented Portugal and acted as expert in Biologicals at the European Medicines Agency (EMA).

At EMA, she was member of the Biologics Working Party for 20 years. She was also member of the Cell

Products Working Party until its closure. She was the Portuguese member at CAT, the Committee for

Advanced Therapies, since its establishment in 2009 until retirement (1/2020). She was also

founding Member of the EU Innovation Network (EU-IN).

During her long experience as a Quality assessor of biological products, she has provided more than

150 scientific advice (national and European) and assessed and peer-reviewed several centralised

European Marketing Authorisation including one Plasma Master File. She was actively involved in

establishing the EU regulatory framework for ATMPs from the very start, involved in the drafting of

the legislation and many of the EMA and European Commission guidelines applicable to ATMPs

including Quality aspects for investigational ATMP, cell based and gene therapy products,

comparability, GMP for ATMPs, GMO

requirements etc.