Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries


The Project “Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries (BERC-Luso)” aims to establish and develop well-grounded, sound, robust and long lasting ethics and regulatory capacities in 4 Portuguese Speaking African Partner Countries, allowing conditions for the development of biomedical research and specifically clinical trials in these countries, in the adoption of international best practices, thus assuring populations’ protection and countries’ development.
About the Project

BERC-Luso is a project of Biomedical Ethics and Regulatory Capacity Building for Portuguese Speaking African Countries, approved and financed by EDCTP2 (The European & Developing Countries Clinical Trials Partnership), with the support of the European Union (EU) and co-financed by the Calouste Gulbenkian Foundation (FCG). It engages 4 sub-Saharan African countries – Angola, Guinea Bissau, Mozambique and Cape-Verde –, working with their NECs and NRAs, in a partnership with Portuguese institutions experts in the field of ethical and regulatory revision - the Portuguese UNESCO Chair in Bioethics (Institute of Bioethics, Portuguese Catholic University), the National Authority of Medicines and Health Products (INFARMED, I.P.), the National Ethics Committee for Clinical Research (CEIC), and the Portuguese Pharmaceutical Society (Competent Authority for Pharmacists);

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Goals

BERC-Luso main goal is to contribute to biomedical ethics and regulatory capacities in the Portuguese Speaking African Partner Countries, acting at the institutional and professional levels, through:


1. Development of a comparative legislative study of the current legal framework and comparison with the international good practices, aiming at implementing these in the partner countries;

2. Development of education and training activities aiming at promoting capacity building in ethical and regulatory revision of the National Ethics Committees (NEC) and National Regulatory Authorities (NRA);

3. Creation of a digital repository in Portuguese language to accompany the current project, to support complementary actions after its term, to widening education, and pose as an example for other projects within the same scope.


Work Packages

BERC-Luso project unfolds in 5 Work Packages: Legislative, Education, Training, Networking, Management, which are briefly presented hereafter.


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1. Legislative Workpackage / De legis
(1st year: October, 2018 to September, 2019)

The Legislative Workpackage aims at promoting, at legislative level, the international good practices related to ethical and regulatory revision of the National Ethics Committees (NEC) and National Regulatory Authorities (NRA).

This main goal will be achieved through the following milestones:

- Development of a study of the legislation in place of NECs and NRAs on the 4 Portuguese Speaking African Partner Countries, and its comparative analysis with the international good practices;

- organization of a Symposium on the Portuguese-speaking African Countries legislation relative to the NECs and the NRAs;

- presentation of suggestions/recommendations towards an ethical-juridical revision of the current legislation.

2. Educational Workpackage / De educationis
(2nd year: January, 2020 to February, 2020)

The Educational Workpackage aims at promoting, at the professionals’ level, capacity building of NECs and NRAs members.

This main goal will be achieved through the following milestone:

- Development of an educational program for capacity building, following an educational program about Clinical Ethics, covering the needs of the involved countries, and considering its cultural features.

3. Training Workpackage / De praxis
(2nd year: December, 2019 to September, 2020)

The Training Workpackage aims at promoting capacity building for qualified and experienced professionals.

This main goal will be achieved through the following milestone:

- Implementation of intensive trainings, in which participants will accurately apply everything they have learned to specific situations such as those they face in everyday practice.

4. Networking Workpackage / De rete
(1st to 3rd year: November, 2018 to September, 2021)

The Networking Workpackage aims at developing powerful digital tools to connect partner institutions, staff and participants along the 3 year project and beyond.

This main goal will be achieved through the following milestones:

- Developing of a website and web networks

- Creating a substantial digital repository of documents, course and training materials, and different tools for ethical and regulatory evaluation.

5. Management Workpackage / De gestionis
(1st to 3rd year: October, 2018 to September, 2021)

The Management Workpackage aims at assuring effective and correct management (activities and financial), along the three years of the project and according to the Work Plan established by BERC- Luso.

This main goal will be achieved through the following dispositions:

- the Executive Board is the body responsible for the coordination of BERC-Luso and in charge of the decisions to be taken as the project unfolds;

- the Management Board is the body responsible for the financial assessment of the project and budget control;

- the Permanent Secretary, which assists the Management Board;

- the IT specialist, which assists the Portuguese Board;

- the Translator, which assists the Portuguese Board.

Structure and Organization

BERC-Luso involves 4 Portuguese institutions experts in the field of ethical and regulatory revision, and will be developed in 4 sub-Saharan Portuguese-speaking African Countries – Angola, Guinea Bissau, Mozambique and Cape-Verde –, working with their National Ethics Committees (NEC) and National Regulatory Authorities (NRA). The involved institutions integrate the Project’s Consortium.



Portuguese Council

The Portuguese Board, which is constituted by four Portuguese institutions, each one designating one representative to compose the Executive Board, together with the Coordinator.

The Executive Board is the body responsible for the coordination of BERC-Luso and in charge of the decisions to be taken as the project unfolds.

The Portuguese Board is constituted by:


Cátedra UNESCO de Bioética do Instituto de Bioética da Universidade Católica Portuguesa
Cátedra UNESCO em Bioética, Instituto de Bioética da Universidade Católica Portuguesa
http://www.bioetica.porto.ucp.pt
represented by Ana Sofia Carvalho and Joana Araújo
CEIC – Comissão de Ética para a Investigação Clínica
CEIC – Comissão de Ética para a Investigação Clínica
https://www.ceic.pt/
represented by Alexandre Quintanilha and Maria Alexandra Ribeiro

INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
www.infarmed.pt
represented by Maria do Céu Machado and Sofia Oliveira Martins
Ordem dos Farmacêuticos
Ordem dos Farmacêuticos
https://www.ordemfarmaceuticos.pt/pt/
represented by Ana Paula Martins and Hélder Mota Filipe

African Partners

The Portuguese Speaking African Partner Countries and their National Ethics Committees (NEC) and National Regulatory Authorities (NRA) are::


Ministério da Saúde de Angola
Angola
Instituto Nacional de Investigação em Saúde
Direcção Nacional de Medicamentos e Equipamentos do Ministério da Saúde
http://www.minsa.gov.ao/
REPÚBLICA DA GUINÉ-BISSAU
Guinea-Bissau
Direcção dos Serviços Farmacêuticos do Ministério da Saúde Pública, Família e Coesão Social
Comité Nacional de Ética em Pesquisa na Saúde – Instituto Nacional de Saúde Pública (CNESP/INASA)

ERIS
Cape Verde
Entidade Reguladora Independente da Saúde (ERIS)
https://www.arfa.cv/
REPÚBLICA DE MOÇAMBIQUE
Mozambique
Direcção Nacional de Farmácia do Ministério da Saúde
http://www.arm.co.mz/

International Institutions

BERC-Luso has partnered with International Institutions who have associated with the project.


UNESCO - United Nations Educational, Scientific and Cultural Organization
UNESCO - United Nations Educational, Scientific and Cultural Organization
https://en.unesco.org/themes/ethics-science-and-technology
WHO – World Health Organization
WHO – World Health Organization
https://www.who.int/

Coordination

The Coordinator of BERC-Luso is Maria do Céu Patrão Neves, Full Professor of Ethics, University of Azores.


Maria do Céu Patrão Neves
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 31 books ando ver 180 published articles.

www.mpatraoneves.pt
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Contacts

BERC-Luso

Contact Form:

BERC-Luso

  • Joana Martins

    Assistente do Projecto BERC-Luso
  • + 351 213 191 397

  • geral@berc-luso.com

  • Rua da Sociedade Farmacêutica 18,
    1169-075 Lisbon
    Portugal



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