The BERC-Luso Project has set up two work teams: one of legal advisors and another of trainees, both including professionals from all partner countries.
The team of trainees consists of five professionals appointed by each partner country. In total, 20 professionals are going to receive training.
Isabel Margareth Malungue
Sampaio Mamba Francisco
José António dos Reis
Maria do Céu Teixeira
Sheila Pinto Monteiro
Marilene Gomes Menezes D'Alva
Cesário Lourenço Martins
Mouhammed Djicó Ould Ahmed
Victor Francisco Gomes
Jamal Mário Paulino
Abrão Jacobe Lemos
São Tomé e Príncipe
Adionilde Aguiar dos Santos
Isaulina Neto Viegas Barreto
Semôa do Espírito Santo
Vânia Juleika de Castro
The team of legal advisors, which is preparing the Comparative Legislative Study, is coordinated by Paula Martinho da Silva and includes the members listed below.
Paula Martinho da Silva
Lawyer, MSc in Bioethics (Faculty of Medicine, Complutense University of Madrid). Senior Researcher (Institute of Bioethics, Portuguese Catholic University).
She was a member and Chairperson of the National Council of Ethics for Life Sciences and Vice-chairperson of the European Group on Ethics in Science and New Technologies of the European Commission.
Member of UNESCO International Bioethics Committee, Champalimaud Foundation Ethics Council, and Central Lisbon Hospital Center.
Graduated in Law (Law School, Universidade Agostinho Neto), head of the Legal Technical Department of the Legal Office of the Ministry of Health (MINSA) and Trainee Lawyer at the Angolan Bar Association (OAA).
João José Mendes Semedo
He holds a degree in Law (Law School, University of Lisbon), a Course in Advanced Studies in Legal Drafting and Science of Law, and a Postgraduate Degree in Legal and Administrative Sciences. He is currently a legal counsel at the Independent Regulatory Entity of Health (ERIS), and from 2011 to 2019, he was a legal counsel at the Regulatory and Supervision Agency of Pharmaceutical and Food Products (ARFA).
He holds a degree in Law, Specialization in Public Administration, and a Postgraduate Degree in Law and Regional Integration Systems (Bissau Law School). He has been a Legal Advisor to Ministers and Secretaries of State for Public Health and the Director of the Legal, Legislation and Administrative Litigation Office.
He holds a degree in Law (Eduardo Mondlane University) and is the Head of the Legal Office of the National Directorate of Pharmacy, a Professor at the Higher Institute of Management, Commerce and Finance, and a member of the Mozambican Bar Association. Currently, he is also an advisor to the National Directorate of Pharmacy.
Graduated in Law (Law School, University of Lisbon), Director of the Legal and Litigation Office of the INFARMED – National Authority of Medicines and Health Products, I.P.
São Tomé e Príncipe
He was born in S. Tomé and Príncipe and has a law degree from Universidade LUSIADA from São Tomé and Príncipe.
He completed a Bachelor's Degree in Biology and Mathematics from the Instituto Superior Politécnico São Tomé and Príncipe.
He was formerly Legal Adviser to the Ministry of Health; Lawyer by profession under number 125A at OASTP; Coordinator of the Law Department at Instituto Médio Politécnico Sercon.
Ana Sofia Carvalho
Coordinator of the UNESCO Chair in Bioethics at the Portuguese Catholic University (UCP); Associate Professor with Aggregation at the Bioethics Institute (IB) at UCP; Researcher at the Center for Studies in Management and Economics (CEGE) at Católica Porto Business School; Member of the European Ethics Group; Member of the National Ethics Council for Life Sciences; Chairman of the Ethics Committee of Hospital da CUF Porto.
Graduated in Clinical Analysis, Master in Bioethics and PhD in Public Health. She worked in the Department of Human Genetics at the National Institute of Health Doctor Ricardo Jorge (INSA) in the molecular diagnosis of genetic diseases (1993-2015), and is currently a researcher in the genetic toxicology laboratory of the same Department. She is a member of the Center for Toxicogenomics and Human Health (ToxOmics) at Universidade Nova de Lisboa. She is a member of the Ethics Committee of the National School of Public Health at Universidade Nova de Lisboa and a member of the Bioethics Committee of the Portuguese Society of Human Genetics (SPGH) of which she is also a member of the Board.
Graduated in Law - Faculty of Law, University of Coimbra, PhD student in Bioethics - Institute for Bioethics, Catholic University of Portugal (IB-UCP), with the theme "Models of consent in Biobanks for research purposes". She is executive secretary of the National Council of Ethics for the life Sciences.
Graduated in Biology, in the field of scientific research, from the Faculty of Sciences of the University of Lisbon, she is a specialist in regulatory matters for clinical research and coordinator of European projects in this area at INFARMED. She has been director of the INFARMED Clinical Trials Unit since its foundation in 2003, until 2019. She has contributed to the development of all clinical trial systems in Portugal. She has been a member of the European Commission's group of clinical trial experts since the beginning of the development of legislation in the area. She collaborates regularly in scientific meetings and training programs in the field of clinical research.
Executive Secretary of the UNESCO Chair in Bioethics at the Portuguese Catholic University (UCP); Professor at the Bioethics Institute (IB) of the Catholic University of Portugal (UCP); Researcher at the Center for Studies in Management and Economics (CEGE) at Católica Porto Business School; European Commission expert in ethical assessment (Marie Curie Grants, European Research Council, H2020). Vice-President of the Ethics Committee of Hospital Luz Arrábida; Member of the Ethics Committee of the Polytechnic Institute of Viseu.
Director of the Clinical Trials Unit of the Directorate for Drug Evaluation of INFARMED, IP, Representative Member of Portugal in the European Group, Clinical Trials Facilitation and Coordination Group (CTFG) since February 2019; Representative Member of Portugal in the Expert Group on Clinical Trials of the European Commission since May 2020. Collaborator with Infarmed since June 2009, in the Clinical Trials Unit and in the Scientific Evaluation Unit of the Directorate for Drug Evaluation. He has a degree in Pharmaceutical Sciences since 2006, with postgraduate training in clinical trials and in the regulation and evaluation of medicines and health
Jorge Batista has been the Technical Secretary for the International Area and Cooperation at the Portuguese Pharmaceutical Society (OF) since 2018, being responsible for the coordination of international activities. He is Executive Manager of the BERC-Luso Project, and member of the Council for Cooperation, and of the Qualification and Admission Council of the OF.
He completed his Integrated Master's Degree in Pharmaceutical Sciences in 2015, and until 2018 he served as a Pharmacist in the Southern Regional Section and Autonomous Regions of the OF, in the strategic development and implementation of the Continuous Professional Development Programme. He is a PhD student in International Health at the Institute of Hygiene and Tropical Medicine (NOVA University of Lisbon), in the specialty of Health and Development Policies.
Clinical Trials Manager in the National Ethics Committee for Clinical Research (CEIC).
Teaching in the Clinical Good Practices Module in the Post-Graduation in Clinical Trials Monitoring, Lusófona University.
Education:Attendance the 3rd year of the Integrated Master in Medicine, Nova Medical School (NMS). Integrated Master in Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon (FFUL). Post-graduation in Clinical Analysis, University of Évora. Degree in Biology, Faculty of Sciences, University of Lisbon (FCUL).
Professional experience: Technical officer in the Health Products Department in the Infarmed, IP. National expert in the European Chemicals Agency at the Environment Working Group of Biocides Products Committee and Ad hoc Environmental Exposure Working Group of Biocidal Products Committee. Technical officer in the Environmental Risks Assessment and Emergencies Unit in Portuguese Environment Agency. Lab technician in clinical analysis and microbiology laboratory in the Military Laboratory of Chemicals and Pharmaceutical Products (Portuguese Army).
Maria Alexandra Ribeiro
Graduated in Biology and PhD in Biology: Physiology and Biochemistry from FCUL; post-graduated in Bioethics from IB-UCP. She is Vice-President of the Ethics Committee for Clinical Research, Visiting Professor at NOVA Medical School|UNL; she is a member of the board of the European Network of Ethics Committees and a representative of Portugal of ethics at European level in clinical trials. She has extensive experience in training in ethics and clinical research (and clinical trials) and several publications in the field of bioethics and clinical research
Maria Do Céu Patrão Neves
The Coordinator of BERC-Luso is Maria do Céu Patrão Neves, Full Professor of Ethics at the University of Azores, specialist in Applied Ethics (Kennedy Institute of Ethics/ Georgetown University). She was consultant on Ethics of Life for the President of the Portuguese Republic, and a Member of the National Ethics Committee for Life Sciences, and of the Board of Directors of the International Association of Bioethics. She is na Expert in Ethics for the European Commission and author/coordinator of 32 books and more than 180 published articles. She has held more than 300 conferences and regularly intervenes in the media and was a member of the European Parliament between 2009 and 2014.
Graduated in Biomedical Sciences from the University of Aveiro, specialising in Pharmaceutical Biomedicine, and a Master's Degree in the Regulation and Evaluation of Medicines and Health Products from the Faculty of Pharmacy of the University of Lisbon. Since 2017, she has been Monitoring clinical trials at the NOVA Clinical Research Unit of the Faculty of Medical Sciences of the New University of Lisbon. In addition to monitoring activities, she performs clinical trial submission activities to obtain a favourable ethical opinion and authorisation from the Competent Authority, and also performs project management functions.