BERC-Luso News
BERC-Luso participates in the Forum of Regulators from Lusophone Countries
BERC-Luso was invited to take part in the Forum of Regulators from Lusophone Countries, organised by the Autoridade Nacional de Medicamento Produtos de Saúde I.P. (INFARMED) as part of its 30th anniversary, which took place on 16 January 2024.
The event, which was attended by the Portuguese Minister of Health, Manuel Pizarro, aimed to bring together the High Authorities for Medicines of the Portuguese-speaking countries in order to develop and consolidate cooperation activities.
BERC-Luso was presented as a successful example of Lusophone cooperation, and its coordinator, Prof. Dr. Maria do Céu Patrão Neves, presented the project in its successive stages of implementation, as well as the impact it has had in terms of revising legislation on biomedical research, creating and organising institutions for the ethical review of scientific projects, and at political, legislative, academic, professional and civic levels. A high level of success was achieved in terms of fulfilling the objectives set at the start of the project in all the partner countries. A total of 311 activities were carried out, with an impact on at least 3848 professionals from different backgrounds. More than 172 hours of training were given and the project was widely publicized through television, radio and media.
The Forum of Regulators from Lusophone Countries also included a round table discussion on "Current perspectives and challenges for regulatory bodies", which was attended by representatives of the various Medicines Regulatory Authorities: Brazil (ANVISA), Angola (ARMED), Cape Verde (ERIS), Guinea Bissau (ARFAME), Mozambique (ANARME), São Tomé and Príncipe (ARFAMED) and East Timor (DNFM).
BERC-Luso in the 11th EDCTP Forum, Paris
BERC-Luso took part in the 11th EDCTP Forum - Partnering for Global Health Research Innovation and Impact in Africa, which took place between 7 and 10 November in Paris. The project's coordinator, Professor Maria do Céu Patrão Neves, presented the abstract "Evaluation of the legislative, educational, training, institutional and social impact of the BERC-Luso Project in Portuguese-speaking African countries", as part of the panel "Strengthening the ethical and regulatory framework".
In the year in which the EDCTP programme celebrates 20 years of activity, BERC-Luso took the opportunity to announce the excellent results obtained at the end of the project. BERC-Luso aimed to develop Ethical and Regulatory Capacity in Portuguese-speaking African countries, acting at institutional and professional level, through the development of a comparative legislative study of the current legal framework and comparison with international good practice and its implementation in partner countries; to develop educational and training programmes to promote capacity building in ethical and regulatory review of NECs and NRAs; and to create a digital repository in Portuguese to accompany the project, support complementary actions after its end, extend training and serve as an example for other projects of the same scope.
This abstract measured and evaluated the overall impact of the BERC-Luso Project in its many dimensions: legislative, educational, training, institutional and implementation of good practices.
In all the partner countries, a high level of success was achieved through the fulfilment of the objectives set at the start of the project. A total of 311 activities were carried out, with an impact on at least 3,848 professionals from different backgrounds. More than 172 hours of training were given, and the project was widely broadcasted through television, radio and the media in at least six countries.
The BERC-Luso project continues active, maintaining close relations between the project's five African partner countries (Angola, Cape Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe), promoting online meetings, webinars and working together to facilitate the partners' work in developing national systems for regulating medicines and capacities for the ethical review of clinical research.
BERC-Luso present in the 81st FIP World Congress of Pharmacy and Pharmaceutical Sciences, Brisbane, Australia
The 81st World Congress of the International Pharmaceutical Federation (FIP) took place last September, from 24 to 28 September, in Brisbane, Australia. This year's theme was "Pharmacy buiding a sustainable future for healthcare - Alingning goals to 2030". BERC-Luso, through Leonor Soares, from the Portuguese Pharmaceutical Association, took the opportunity to publicise the results obtained during the project, with the presentation of a poster "Global Evaluation On The Impact Of The BERC-Luso Project" and an oral presentation "Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries- BERC-Luso".
A set of indicators was co-constructed between BERC-Luso partners, developing a national roadmap with actions to lever development at different levels. Roadmaps included strategic actions to reinforce ethics and regulatory capacities in each country. Indicators were evaluated at the end of the project (not completed, partially completed, completed) and compared with the action’s descriptive analysis. Score points were attributed to each indicator, with the calculation of score mean values. From 57 defined (the set of indicators defined for the 5 countries), 63.16% were fully completed and 36.84% were partially completed. All proposed objectives were completed. Analysis per country shows varying degrees of success (from 60.00% to 96.43%). Overall, a high level of success (78.59%) was achieved through roadmap and indicators’ analysis.
BERC-Luso had a high impact in all the partner countries, with the development of a sense of community and ownership due to the different bottom-up and top-down approaches. All the activities that were carried out during the project period were considered a success, having achieved the proposed objectives.
BERC-LUSO IN MOZAMBIQUE
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.
BERC-Luso project once again featured in the EDCTP newsletter
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
BERC-LUSO VISITS ANGOLA
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.
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
Following its tour of African partner countries, the BERC-luso coordination team will be in Cape Verde from April 6 to 10.
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
BERC-LUSO VISITS SÃO TOMÉ AND PRÍNCIPE
The BERC-Luso coordination team composed by the Professor Maria do Céu Patrão Neves (President of the National Ethics Council for Life Sciences and Coordinator of the BERC-Luso Project), Professor Maria Alexandra Ribeiro (President of the Ethics Committee for Clinical Research), and Dr. Jorge Batista (Advisor for the International Area of the Portuguese Pharmaceutical Association and Executive Manager of the BERC-Luso Project) traveled to São Tomé and Príncipe between February 28th and March 4th, to monitor the last Work Package 4 - De rete or Networking of the project.
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.