On July 18th, at 6.30pm (Lisbon local time), another webinar will take place, this time organized together with the BERC-Luso Angola team (the coordination project will visit this country on July 25th) dedicated to "The importance of biomedical research in Angola".

On March 16^th, another BERC-Luso webinar took place, this time dedicated to the topic "The importance of biomedical research in Cape Verde". Dr. Lenira Centeio, Technical Officer of the Directorate of Pharmaceutical Regulation of the Independent Regulatory Authority for Health (ERIS) and Dr. José António dos Reis, Chairman of the National Ethics Committee for Health Research of Cape Verde (CNEPS) were the speakers chosen by the BERC-Luso Cape Verde team to lead the meeting.

Dr. Lenira focused her presentation on the situation of biomedical research in this country, the issue of regulation at the level of standards and guidelines. One of the central issues of the discussion was the urgent need to create specific legislation to frame the theme of biomedical research. The role of  of ERIS was also presented, its purpose on the technical and economic regulation of the activity of health care establishments, pharmaceutical and food sectors.

Dr. José António dos Reis spoke of the need to integrate Cape Verde into platforms for scientific research and presented the recently created National Coordination and Monitoring Commission (CNCA), chaired by the National Health Director and whose mission is to prepare and review the regulatory framework on biomedical and other medical research and also on matters of Ethics in Public Health Policies. Currently Cape Verde still does not have specific legislation that allows the practice of clinical research in the country, which is a limiting factor in terms of investment and development.

This webinar is part of a set of 5 webinars that be held by each of the partner countries in order to prepare the visit to each of these countries, taking into account the implementation of the last Work Package 4 - De rete ou Networking of the BERC-Luso Project. The next webinar will take place on 30^th March and Guinea Bissau team will be in charge of the organization.

Another BERC-Luso webinar took place on the 11^th of February, this time dedicated to "The importance of clinical trials in São Tomé and Príncipe", presented by Dr. Jeryson Ramos and Dr. Adeonilde Aguiar, both members of the BERC-Luso team in this country.

Dr. Jeryson began presented the possible impact that Clinical Trials may have in Sao Tome and Principe, whether in terms of creating its own structures for this purpose, training health professionals, institutions and possible financial potential. To date, this activity is not practiced in this country, nor is there national legislation about this subject yet.

Dr. Adeonilde Aguiar, in the capacity of President of the National Ethics Committee of the Ministry of Health spoke about the fundamental role of the Ethics Committees at the level of Clinical Trials. For this Committee, the main focus should be the protection of participants in clinical trials, and they also have the duty to promote the guarantee of their adequate implementation, scientific and ethical robustness, quality and integrity of the data generated in a clinical trial.

This webinar is part of a set of 5 webinars that be held by each of the partner countries in order to prepare the visit to each of these countries, taking into account the implementation of the last Work Package 4 - De rete ou Networking of the BERC-Luso Project.

The BERC-Luso and LiberHetica consortia meet on 26th March 2021 to discuss about Biomedical Ethics and Regulatory Capacity Building in Sub-Saharan African countries.The BERC-Luso and LiberHetica are two projects funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) aimed at strenghting ethics and regulatory capacities for clinical trials by partnerships between African and European countries, and involving six Sub-Saharan African countries ( Angola, Cape Verde, Guinea Bissau, Mozambique, Sao Tome and Principe and Liberia) and two European countries (U.K. and Portugal).

On the 11th of February takes place the session "Legislative and Institutional Impact of BERC-Luso in the PALOP", at 05:00 pm (GMT), through the zoom platform.

In this webinar the speakers present the latest legislative and institutional developments in the respective partner countries.

Ms. Joana Morais (INIS - Angola), Ms. Ester Oliveira (ERIS - Cape Verde), Mr. Mouhammed Ahmed (INASA - Guinea-Bissau), Mr. Jeryson Ramos and Ms.  Vânia Castro (MS - Sao Tome and Principe)  participate in the event.

The session is moderated by Professor Maria do Céu Patrão Neves.

The next BERC-Luso webinar will take place in November and includes two sessions:

• On 6^th November, between 12:00 and 13:30 pm, the session "Biobanks" takes place with the intervention of the speakers Dr. Cíntia Águas and Dr. Célia Ventura;
• On November 20, between 12:00 and 13:30 p.m, the session "Monitoring of Clinical Trials" takes place, under the guidance of Dr. Maria Pais and Prof. Maria Alexandra Ribeiro.

Both sessions are moderated by Professor Maria do Céu Patrão Neves.

The 3rd Webinar of BERC-Luso, dedicated to the theme "Achievements and challenges of berc-luso partners" takes place on October 16, with the participation of partners from Cape Verde, Guinea-Bissau and São Tomé and Príncipe and on the 30th of the same month with the intervention of Angola and Mozambique.

Both sessions take place at 12:00 p.m. by zoom.

The pandemic situation we are experiencing has led to the postponement of activities planned by BERC-Luso, imposing a different pace in the continuation of the project. Therefore, the joint face-to-face work, initiated in Cape Verde in February, cannot be resumed next September in Lisbon, at the time of the internship. In this sense, it is considered essential to create forms of interaction that allow us to continue the development of the purposes of BERC-Luso, even in the current adverse conditions. It is in this context that it is proposed to hold a 2nd e.Forum, this time dedicated to Clinical Research: principles and procedures.  This Forum will operate monthly and will have a brief thematic introduction by a representative of the responsible institutions BERC-Luso, backed by another brief intervention by a representative of one or two partner countries, followed by discussion among all. Where appropriate, succinct documentation shall be attached to the respective sessions. Each session will last for an hour and a half, taking place on the Zoom platform, being recorded and placed in the private section of the BERC-Luso website.

Program:

26th June, 12h-13h30 p.m/Lisbon

24th July 12h-13h30 p.m/Lisbon

28th August, 12h-13h30 p.m /Lisbon

25th September, 12h-13h30 p.m/Lisbon

The pandemic situation that the world is going through has led to profound changes in all categories of individual and social activity, forcing a constant effort to adapt to new realities and respond to current needs. The BERC-Luso also follows this dynamic. In this context, BERC-Luso, faithful to its design of ethical and regulatory training in the field of biomedicine and wanting to contribute to the better response of partners to the extraordinary demands of pandemic times, organizes a thematic Debates Forum, under the common name “ Best practices in pandemic times ”.

The webinar will contain a brief thematic introduction by the person in charge of the session in question, followed by debate between all participants.

Program:

May 15(12 pm- 13pm /Lisbon)

–Community masks: manufacture, access and use -
Mr. Jorge Batista and Professor Patrão Neves

May 22 (12 pm-13 pm /Lisbon)

– Informed consent in pandemic time: clinical assistance and biomedical research -
Professor Patrão Neves and  Professor Alexandra Ribeiro

May 29 (12 pm-13pm/Lisboa)

– Clinical research: pandemic-time procedures -
Mr. Rui Ivo and Professor Alexandra Ribeiro

June 5 (12pm-13pm/Lisbon)

– Clinical research and innovation -
Professor Ana Paula Martins and Professor Helder Mota Filipe

The Training, has the participation of trainers representing the various partners of the Consortium Portuguese, the Portuguese authorities specialized in the ethical and regulatory review of clinical trials, namely the UNESCO Chair of Bioethics of the Portuguese Catholic University, the Ethics Commission for Clinical Research, the INFARMED (National Authority of Medicine and Health Products I.P.), and the Portuguese Pharmaceutical Society. The United Nations Educational, Scientific and Cultural Organization (UNESCO) and the World Health Organization (WHO) also participate in this training, which will be represented by the main leaders of the sections dedicated to ethical training and global health.  The event is co-organized by two prestigious Cape Verdean institutions: The Independent Health Regulatory Authority and the National Committee of Ethics in Health Research. The participants are professionals, with relevant responsibilities, in Angola, Guinea-Bissau, Mozambique, S. Tomé and Príncipe and Cape Verde.

The Program highlights the Opening Session, which takes place on February 17, at 9:00 am, at the headquarters of the Cape Verde Medical Society; the formal sitting, at 06:30 pm on February 21, with the presence of the Minister of Health and Social Security of Cape Verde, Mr. Arlindo do Rosário; and the Commitment Celebration Session, at 04:30 pm on 22 February, with interventions by WHO  and UNESCO representatives.

This training programme is part of the second of five BERC-Luso Project Action Programmes, entitled "Educational". The first workpackage,  which took place between 2018 and 2019, developed a comparative study of partner country legislation with international best practices in biomedical research, in order to strengthen the current legislation and thus to enable clinical research to take place for the benefit of the population, also contributing to the scientific and economic development of partner countries.

Download the program of the training

The BERC-Luso organized the Symposium “International Best Practices in Clinical Research: A Partnership with Portuguese-Speaking African Countries” on June 6, 2019, at Infarmed in Lisbon.

The goals of this Symposium included the presentation of the Comparative Legislative Study, a discussion on best practices in clinical research and the unveiling of the Project website.

The State Undersecretary of Health, Francisco Ramos, and the State Secretary of Foreign Affairs and Cooperation, Teresa Ribeiro, opened the Symposium, bearing testament to the Government's support and to the relevance of this project for strengthening the cooperation between the Portuguese-speaking countries.

The program of the Symposium included a general presentation of the activities to be developed during the three years of the project, which includes five Work Packages. The first Work Package is devoted to legislation and includes a comparative legislative study of the ethical and regulatory framework in the field of clinical research in the different countries. This upcoming study aims to define a common ethical and regulatory framework, across the different countries, aligned with the best international practices in the field of clinical research. It was presented by the legal advisors of the BERC-Luso and discussed during one of the panels of the event. The Symposium also included a panel of Ambassadors and official embassy representatives from the project’s partner countries.

The Symposium was the first public event of the BERC-Luso Project and also the moment for the unveiling of the project’s official website, www.berc-luso.com, which is the main platform of communication between the countries involved in the project.

Download the program of the Symposium

www.berc-luso.com/simposio/

The BERC-Luso organized the Workshop “International Best Practices in Biomedical Research: Ethical and Legal Requirements” on June 3-5, 2019, at Infarmed in Lisbon.

This workshop was part of the “Work Package 1: Legislation” and the ongoing Comparative Legislative Study and specifically aimed to:

- deepen the analysis of the current national laws of the partner countries based on international best practices

- lay the groundwork to integrate international standards into national law and prepare their future implementation

The workshop brought together the BERC-Luso team of legal advisors, which includes representatives from partner countries and Portuguese lawyers, along with representatives from the embassies of partner countries in Portugal. The workshop was coordinated by Maria do Céu Patrão Neves, Full Professor of Ethics and BERC-Luso coordinator, João de Almeida Pedro, Senior Project Manager of the Calouste Gulbenkian Foundation, Helder Mota Filipe, President of the Council for Cooperation of the Portuguese Pharmaceutical Society, Joana Fonseca e Castro, Director of the Infarmed Legal Office, and Paula Martinho da Silva, coordinator of the team of legal advisors.

Download the program of the Symposium