BERC-LUSO VISITS GUINEA BISSAU
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 25th to 29 th of July.
BERC-LUSO IN CAPE VERDE
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
ID of meeting: 831 6781 6011
BERC-LUSO VISITS SÃO TOMÉ AND PRÍNCIPE
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.
BERC-Luso on the television program “Diálogo à tarde” on TVS in São Tomé and Principe
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.
BERC-LUSO IN SÃO TOMÉ E PRINCIPE 28th February to 4th March 2022
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 28th February and 4th 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!
BERC-Luso in the 10th EDCTP Forum Equity in research for health
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.
webinar - The drug circuit in clinical trials and the protection of participants
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.
INTERNSHIP: From praxis | Training at CEIC and INFARMED. IP
The internship of BERC-Luso Project, “Biomedical Research and Clinical Trials: Regulatory Training and Ethics”, will take place from 12 to 18 of September, in Lisbon – Portugal in INFARMED and CEIC.
This internship consists of a 6 day´s of practical training, in a total of 50 contact hours. The program can be consulted on the link below.
The internship will take place in a face-to-face system, ensuring all precautions and restrictions within the scope of the control of the pandemic against COVID-19.
On June 17th, another webinar dedicated to the analysis of cases took place, presented by Professor Maria Alexandra Ribeiro, who presented a case of a prospective, randomized (1:1) open and multicenter clinical trial phase IIIb/IV to assess the efficacy and safety of the drug compared to clinical practice.
The case study was based on an experimental drug capable of reversing anticoagulation due to uncontrolled or life-threatening bleeding. With the case study presented, we intended to discuss tree main issues: obtaining consent to participate in the study in view of its specificities, as well as the patients to be included (emergency situation); acceptable risk-benefit ratio under conditions where the patient is unable to provide consent; and integrity/validity of the study data, due to the possibility of bias in the results due to the exclusive inclusion of less severely ill patients that were able to consent.
It was a very participated event and although the existence of clinical trials is not yet a reality in all countries involved in the project, the desire for these to become a national reality was commonly expressed. Another issue that was also widely discussed was informed consent, not only because of how it can/should be obtained in clinical trials but in other more specific situations, namely in persons unable to consent.
The next webinar is scheduled for the 8th of July at 17.00h and Professor Helder Mota Filipe will be in charge of the presentation.
WEBINAR - Analysis of practical cases
On June 17, 2021, we will have another webinar dedicated to the analysis of practical cases.
Prof. Maria Alexandra Ribeiro (CEIC) will presented the case and the moderation will be made by Prof. Maria do Céu Patrão Neves.