The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Guinea Bissau, via electronic platform, with the presence of Ms. Zeferina Costa, Mr. Mouhammed Ahmed and Mr. Cesário Martins.

The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as maintaining contact between partner countries and the BERC-Luso project, promoting the development of thematic webinars.

BERC-Luso coordination meets on the 5th of May 2020 with the trainees of the Democratic Republic of São Tomé e Príncipe, via electronic platform, with the presence of Mrs. Semôa Espírito Santo and Mr. Jeryson Ramos.

The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as the promotion of webinars aiming at discussing relevant topics to all partner countries, whilst maintaining a link of communication between countries. 

On the afternoon of the last day of work, on 22nd  February, takes place the Commitment Celebration Session of the Training Action of the BERC-Luso Project. The main objective of this session is to celebrate the commitment of all participants from BERC-Luso partner countries, in relation to the best practices in healthcare and clinical research, to be implemented in the present and in the future, formulated under the designation of the “Declaration of Commitment ”.

The Session begins with a debate moderated by Professor Helder Mota Filipe and welcoming Mr. Andreas Reis, representative of the World Health Organization (WHO)  and  Professor  Dafna Feinholz, representative of UNESCO. Participants from partner countries thus have the opportunity to clarify questions about the activities of these organizations and explore possible points of collaboration.

Subsequently, representatives of the BERC-Luso partner countries present the Declarations of Commitment: Mr. Mamba Sampaio (Angola), Mr. Victor Gomes (Guinea Bissau), Mrs. Telma Chicuamba (Mozambique), Mrs. Semôa Sousa (São Tomé and Príncipe), and by Cape Verde Mrs. Lenira Centeio, Mrs. Maria de Lourdes Monteiro and Professor Antonieta Martins. These Declarations of Commitment reflect a set of actions to be developed in the various countries, with the aim of improving the conditions and installed capacity for the development of biomedical research and clinical trials.

The trainees from all countries formally deliver to the WHO and UNESCO representatives, Mr. Andreas Reis and Professor Dafna Feinholz, respectively, a partnership proposal for support and training in the areas of ethical and regulatory review, as well as requesting support in concrete actions. The representatives of international institutions formally present to all training professionals a document containing a set of publications and teaching material, fundamental for the training of these professionals and their countries. The partnership between Angola, Cape Verde, Guinea Bissau, Mozambique, São Tomé and Príncipe, the World Health Organization and UNESCO, will allow the establishment of direct contact points with support for the continuation of training initiatives in the area of ethical and regulatory review in the various countries.

The Closing session is done by the Coordinator of BERC-Luso, Professor Maria do Céu Patrão Neves, and the Executive Project Manager, Mr. Jorge Batista.

The representative of the World Health Organization (WHO), Dr. Andreas Alois Reis, holds the session on "Ethics in Global Health", on the morning of February 22nd. Then, Professor Dafna Feinholz, representative of UNESCO, presents the session on "Bioethics and Ethics in Science and Technology". Both sessions aim to make known the action of WHO and UNESCO in the field of ethical and regulatory training in the domain of care and biomedical research, thus presenting the main programs implemented by these institutions in these areas.

The representative of the Pharmaceutical Society, Professor Helder Mota Filipe,  and the representative of INFARMED, Mrs. Helena Beaumont promote training with the theme  "Regulation of Clinical Trials" on February 21^st .

This training promotes access to a broad knowledge of medicines regulation, including national and European regulatory framework. The regulatory framework and best clinical and manufacturing practices are contextualized. The module focuses particularly on guidelines for the conduct and assessment procedures of clinical trials, thus ensuring the theoretical basis for the intensive internship that takes place in September 2020.

The formal sitting of the Formation of the BERC-Luso  Project  takes  place  on  the  afternoon  of  21^st  February. The session has the intervention of the Coordinator of BERC-Luso, Professor  M. Patrão Neves; the intervention of a representative of the group  of  trainees from each of the partner countries of the Project  –  Mr. Adelino Quiteque (Angola), Mrs. Marilene D'Alva (Guinea Bissau),  Mrs. Telma Chicuamba (Mozambique),  Mrs. Camila Barros (S. Tomé e Príncipe )  and  Mrs. Maria de Lourdes Monteiro (Cape Verde) – and intervention of His Excellency  the Minister of Health and Social Security of Cape Verde, Mr. Arlindo do Rosário.

The trainees present the Contextualization Report on Biomedical Research and Clinical Trials in each of their countries, showing the initiatives developed in regulatory and ethical matters.

His Excellency Minister of Health and Social Security of Cape Verde, Mr. Arlindo do Rosário congratulates the BERC-Luso Project for its dimension and capacity to bring together the PALOP with national and international institutions, and reinforces the commitment made to the development of attractive conditions for the establishment of Clinical Trials in Cape Verde.

After the end of the session, a Solemn Dinner is followed with the presence of institutional guests at the Hotel Oasis Atlântico Praiamar.

The session "Ethics of Clinical Trials" takes place on February 20, taught by Professor Maria Alexandra Ribeiro and Mrs. Lénia Costa, representatives of the Ethics Committee for Clinical Research (CEIC) of Portugal. This module aims to promote an education and training for ethical and regulatory evaluation and monitoring of clinical trials that safeguard the rights, safety, and well-being of all trial subjects, with special attention for clinical trials involving vulnerable subjects, for the wide-ranging exercise of the NRAs.

In particular, understand the responsibilities and the procedures required for NECs on assessing clinical trials.

On February 19th, Professors Ana Sofia Carvalho and Joana Araújo, from the UNESCO Chair of the Institute of Bioethics of the Catholic University of Porto, realize the training session with the theme "Scientific Research Ethics and Public Research Policies". This dynamic session aims at the acquisition of new knowledge and training on fundamentals and principles of scientific research ethics, as well as the identification of ethical problems and deliberative processes, in the understanding of the analytical tools that boost the performance of case analysis and ensuring ethical decision.

The session has the application of practical cases, fundamental for the acquisition of ethical review skills.

Professor Ana Sofia Carvalho and Professor Joana Araújo, representatives of the UNESCO Chair of the Institute of Bioethics of the Catholic University of Porto organize training on the theme "Clinical Ethics and Public Health Policies" on February 18th. The session promotes an excellent education for ethical, analytical and critical assessment of care situations liable to the respect for human dignity and of the public health policies those defy social justice, for the wide-ranging exercise of the National Ethics Committees.

The Coordinator of BERC-Luso Professor Maria do Céu Patrão Neves and Mr. Bruno Cordeiro, representative of INFARMED organize the training with the following theme "Legal dispositions and ethical best practices" on the afternoon of February 17^th. The session takes place at the Hotel Oasis Atântico Praiamar, and aims  to implement the development of an adequate legal framework for the full and effective functioning of the NECs and NRAs and implement the best international practices concerning the ethical and regulatory evaluation of health policies and research protocols.

The Comparative Legislative Study is presented: International Best Practices and Legislative Challenges, resulting from the work developed during the first year of the BERC-Luso Project.