The coordination of BERC-Luso was in Mozambique from 31 August to 3 September. This was the last trip of the coordination to the partner countries, under the Work Package 4 action plan - De rete ou Networking.

            The visit included an audience with the Vice-Minister for Health, meetings with National Medicine Regulatory Authority (ANARME) and the National Bioethics Committee for Health (CNBS), a visit to the National Institute of Health (INS) and to the Health Research Centre of Polana Caniço, as well as a meeting with the Faculty of Medicine of Eduardo Mondlane University. The meeting ended with a conference about "The importance of biomedical research in Mozambique" held in the Aula Magna of the Faculty of Medicine of Eduardo Mondlane University, which was attended by over 50 professionals representing institutions linked to the Ministry of Health, as well as professionals from various areas of health sciences, social sciences and others.

The Mozambique team has been raising awareness among its peers and stakeholders for this topic, being a team with a strong medicine regulatory component, and is becoming very effective in the synergies it has built, managing to overcome the adversities that have regularly arisen.

The July EDCTP newsletter refers to the visit of the BERC-Luso Project’s Coordination to Guinea-Bissau. The project has been regularly reported in the monthly newsletters of this public partnership between institutions mandated by national governments in Europe and sub-Saharan Africa, and supported by the European Union.

For further information, follow the link:

https://www.edctp.org/web/app/uploads/2022/08/EDCTP-Update-July-2022.pdf

The BERC-Luso project is in its final phase of activity and the last stage involves an official visit of the Coordination team to all the partner countries. Between 26 and 29 July, it was Angola's turn.

These were three very intense, but very fruitful days, to strengthen the relations between the two countries regarding the objectives of the project, namely in terms of Ethics and Regulatory Capacity Building in the field of biomedical research.

The visit began with a technical meeting with the BERC-Luso group from Angola, which was followed by an audience with the Portuguese Ambassador in Angola (Francisco Alegre Duarte). Meetings were also held with the President of the different professional associations: the Medical Association (Elisa Gaspar), the Pharmacists Association (Santos Morais Nicolau), the Biomedical Association (Joaquim Castigo Levita) and with the Nurses Association (Paulo Luvualo). The programme also included a meeting and visit to the Ethics Committee of the National Institute for Health Research (INIS), the Regulatory Agency for medicines and Health Technology (Armed) and the Faculty of Medicine of Agostinho Neto University.

One of the highlights of the visit was the Conference on "The importance of biomedical research in Angola" that took place in the Pepetela Auditorium of the Portuguese Cultural Centre, with the participation of around 50 professionals from various areas of health sciences, social sciences and others.

The last visit under this final stage of the project will be to Mozambique from 31 August to 2 September.

Last April, between 10 and 14, the BERC-Luso coordination visited Guinea Bissau. The plan of the visit included meetings with national authorities of the country, hearings with political power, a meeting with the Ambassador of Portugal, a Conference of the National Committee of Ethics in Health Research and BERC-Luso, and a visit to one of the oldest projects in the country – The Bandim Health Project.

The official visit of the BERC-Luso Coordination to Guinea-Bissau considers that this mission was a signable success, above expectations.

The next steps to get the approval of the various documents proposed to the political power now go through a follow-up in their critical moments, namely the discussion in the National People's Assembly. Also at the institutional level, actions to be implemented were identified that allow the effective functioning of the institutions.

Following these visits, the next one will be to Angola from 25^th to 29 ^th of July.

The visit will include meetings with national authorities and political leaders, a meeting with the ambassador of portugal, a public event on clinical trials and biomedical research with the participation of the Cape Verde BERC-Luso team and the BERC-luso coordination, and visits to several national entities relevant to the project.

You can access the public event program here

This session will be broadcast live via the zoom link:

Topic: The Importance of Biomedical Research in Cape Verde

https://us02web.zoom.us/j/83167816011?pwd=MHhzNkYwbzlIRU4wYVYvT21xQ05GUT09
ID of meeting: 831 6781 6011
password: 818830

During the four days of intense work, the BERC-Luso team met with the Minister of Health of Sao Tome and Principe (Filomena Monteiro), with the Vice-President of the National Assembly of the Republic of Sao Tome and Principe (Guilherme Octaviano), with the President of the Sao Tome and Principe Medical Association (Celso Matos), with the Ethics Committee of the Ministry of Health which includes two members of the local BERC-Luso team, and also had an audience at the Embassy of Portugal in Sao Tome and Principe with Ambassador Rui Carmo and the Attaché for Cooperation of the Embassy (Paula Pereira),

Several visits were also made to strategic structures for the project's implementation, namely the National Tuberculosis/HIV Reference Laboratory and the Pharmaceutical Department.

A key moment of the visit was the workshop on clinical trials and biomedical research in São Tomé and Príncipe held at the Portuguese Cultural Center, with the participation of more than 50 professionals and students from various areas of health sciences, social sciences and others. The debate panels were very well attended, with a great interest from the speakers and with presentations of high level and an interested debate, besides the very significant opening and closing speeches.

The official visit of the BERC-Luso Coordination to São Tomé and Príncipe was a remarkable success, exceeding the expectations initially outlined.

The next steps to achieve the definition of a robust legislation in the area of competent institutions (Medicines Regulatory Authority and Ethics Commission), as well as its regulations, now include the involvement of political power and awareness on this issue.

As part of the visit to São Tomé and Príncipe last March, members of the Coordination of BERC-Luso and BERC-Luso São Tomé and Príncipe participated in the television program "Diálogo à tarde" of TVS. Interviewed by journalist Maximino Carlos, BERC-Luso Coordinator, Maria do Céu Patrão Neves, and BERC-Luso STP members Semôa Santos and Jeryson Ramos, shared the Project's main objectives, its implementation in São Tomé and Príncipe, and the results expected from the Project's impact in the country.

The Television Program "Diálogo à Tarde" on TVS is a space for discussion on various topics of interest to the São Tomé society, being a privileged place of communication to the general population.

The BERC-Luso coordination team will visit each of the partner countries, fulfilling the requirements of the project to assess its real impacts in Angola, Cabo Verde, Guinea-Bissau, Mozambique, S. Tomé and Príncipe. At the same time, BERC-Luso trainees in each of the partner countries are preparing an on-site programme to promote and disseminate the project but, above all, to train their colleagues and fellow colleagues. This will be a demanding programme to be prepared as a team, with anticipation and dedication, and suited to the target audience. This last work package aims at deepen the levels of connection between all partners and those of external dissemination of the project, consolidating long lasting and sustainable bases for effective and wide exchange, ensuring constant updates and continuous education and training.

The first official visit will take place in São Tomé and Príncipe between 28^th February and 4^th March. The visit plan includes meetings with the country's national authorities and high-level meetings the political stakeholders, a meeting with the Portuguese Ambassador, a public event on clinical trials and biomedical research with the participation of the São Tomé and Príncipe BERC-Luso team and the BERC-Luso coordination, and visits to several national entities relevant to the project.

Visit the website www.berc-luso.com to keep up with the latest developments of this project!

EDCTP has sought to promote the strengthening of the relationship between Africa and Europe, still marked by strong differences at the level of scientific research.

BERC-Luso, through its activities, intends to mitigate these differences by collaborating with the five African countries (Angola, Cape Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe) in order to facilitate their development and strengthening of national medicines regulatory systems and capacities for ethical review of clinical research. During the Forum, the project was highly applauded, namely for being one of the few involving Portuguese-speaking African countries, often excluded from international projects.

It took place, on the 8th of July, the last webinar dedicated to the analysis of cases, presented by Prof. Helder Mota Filipe with the theme “The drug circuit in clinical trials and the protection of participants”.

The basic factors to guarantee the quality of the medicine circuit, the fundamental principles, the physical conditions, the human resources with specific training in good clinical practices and good pharmacy practices were presented, to promoting the guarantee of an adequate implementation, with the focus on the protection of participants, the robustness, the quality and integrity of the data generated in the clinical trial.

Another issue addressed was the responsibilities of the clinical trial sponsor, not only during the trial, but also after the trial, namely with the follow-up and monitoring of participants.

The new reality of clinical trials in view of the COVID-19 pandemic, the need for adaptation, the participant's rights, the record time in which vaccines were obtained, the testing of existing drugs and new drugs were also addressed. Again, the issue of informed consent in these borderline situations was discussed.

Prof. Helder Mota Filipe ended his intervention leaving several points for discussion: how to increase the number of clinical trials in PALOPs; how to create the necessary conditions for their execution; how to resolve the material and human resource requirements in the main hospital institutions and what is the possible contribution of BERC-Luso to overcome these issues. The webinar had a massive participation of all countries involved, which allowed a wide discussion of the proposed issues. This was the last webinar before internship in Lisbon, and Prof. Helder left the challenge of organizing a pilot trial in different countries. Certainly this will be a widely discussed topic in the week of September 12th to 18th.