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Webinar "Biobanks"

November 2020

On the 6th of November, the webinar on "Biobanks" takes place, through the zoom platform, with the participation of Mrs. Cíntia Águas, a legal expert and phd student in bioethics at the Institute of Bioethics, Catholic University of Portugal and Mrs. Célia Ventura, Researcher in the genetic toxicology laboratory of the department of human genetics, at the National Health Institute Doutor Ricardo Jorge.

A biobank is an entity that collects, processes, organizes, stores human biological materials, associating clinical, genetic or other information with them for exploratory research and clinical trials. Biobanks are abundant, heterogeneous and sparsely regulated. They are at the intersection of ethics, science and politics, putting researchers, decision-makers and citizens into dialogue. Broader models of consent for the sharing of samples and data should therefore change the focus of the information provided and be complemented by ethical and governance structures. Only in this way they will be able to respect people's dignity and assume themselves as reliable accelerators of biomedical research, which acquires special importance in the context of a pandemic.

In the context of the session are also presented some examples of consortia of Portuguese, European and African biobanks and their contribution to the development and availability of harmonised models of SOPs and informed consent. The general governance structure of a biobank and its way of operating is described, as well as the measures to be implemented to ensure its ethical requirements. Among these, we highlight the central role of the biobank ethics committee in the evaluation of procedures for the conservation and sharing of biological samples and associated data, the information to be made available to participants in informed consent and criteria regarding the dissemination of results and incidental findings obtained in research.


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Session "Achievements and challenges of BERC-Luso in Angola and Mozambique"

October 2020

On the 30th of October, the session "Achievements and challenges of BERC-Luso in Angola and Mozambique”.

In representation of the partner countries, Mrs. Katiza Mangueira and Mrs. Telma Chicuamba give their testimony.

The overall appreciation of the developments of the Project in partner countries is positive, being transversal to all the importance of training and the exchange of experiences between Portuguese professionals and trainees from Portuguese Speaking African Countries, as well as contact with new paradigms in biomedical research, with emphasis on training in Cape Verde "Biomedical Research and Clinical Trials : Ethics and regulatory capacity building ", organized during the week of 17 to 22 February 2020, in Praia,  Cape Verde.

The presentations also focused on the relevance of the webinars that take place during this year, allowing the exchange of experiences, continuous training and the acquisition of new knowledge in the central themes of BERC-Luso.


BERC-Luso

Session - Achievements and challenges of BERC-Luso in Cape Verde, Guinea-Bissau and Sao Tomé and Príncipe

October 2020

On the 16th of October, the session "Achievements and challenges of BERC-Luso in Cape Verde, Guinea-Bissau and Sao Tomé and Príncipe”.

In representation of the partner countries, Mrs. Maria de Lourdes Monteiro, Mr. Mouhammed Ahmed and Mrs. Isaulina Barreto give their testimony.

The overall appreciation of the developments of the Project in partner countries is positive, being transversal to all the importance of training and the exchange of experiences between Portuguese professionals and trainees from Portuguese Speaking African Countries, as well as contact with new paradigms in biomedical research, with emphasis on training in Cape Verde "Biomedical Research and Clinical Trials : Ethics and regulatory capacity building ", organized during the week of 17 to 22 February 2020, in Praia,  Cape Verde. This moment is considered extremely relevant by all because it has given the opportunity to know more deeply the legal framework, the gaps in biomedical research and the tools necessary for the proper functioning of the National Ethics Committees and the Regulatory Authorities of Medicines in the different countries.

The presentations of Cape Verde, Guinea-Bissau and Sao Tomé and Príncipe also focused on the relevance of the webinars that take place during this year, allowing the exchange of experiences, continuous training and the acquisition of new knowledge in the central themes of BERC-Luso.


BERC-Luso

4th webinar "Good Clinical Practices in the Construction of Scientific Evidence"

September 2020

On the 25th of September, the 4th session of the monthly Webinar Forum of the BERC-Luso project dedicated to the theme "Good Clinical Practices in the construction of scientific evidence" is held under the intervention of Mr. Joel Passarinho from the National Medicines and Health Products Authority, I.P. (INFARMED).

The consensus of the global scientific community, around what is considered the Good Clinical Practices applicable to clinical research in human beings, is a remarkable example of international cooperation.

The guideline for Good  Clinical Practice (ICH E6), was first published in 1996, and since then it has been considered the basis, the reference, for the realization of clinical investigation of recognized quality according to the highest ethical standards. Consistent, with reliable, accurate and demonstrable results produced and at the same time this same information is recorded ensuring the confidentiality of the participants, their rights, and the protection of their integrity.

Only by demonstrating its effective compliance with the data collected as scientific evidence will it allow an entity to request from the regulatory authorities of medicines product an application for marketing authorisation (MA) for a new medicine.


BERC-Luso

Online meeting with the trainees from Angola

September 2020

The coordination of BERC-Luso meets, on the 16th of September, with the team of trainees from Angola.

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 status of the commitment drawn up in Cape Verde.


BERC-Luso

Online meeting with the trainees from Mozambique

September 2020

The coordination of BERC-Luso meets, on the 15th of September, with the team of trainees from Mozambique.

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 status of the commitment drawn up in Cape Verde.


BERC-Luso

Online meeting with the trainees from Guinea Bissau

September 2020

The coordination of BERC-Luso meets, on the 15th of September, with the team of trainees from Guinea Bissau.

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 status of the commitment drawn up in Cape Verde.


BERC-Luso

Online meeting with the trainees from Cape Verde

September 2020

The coordination of BERC-Luso meets, on the 15th of September, with the team of trainees from Cape Verde.

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 status of the commitment drawn up in Cape Verde.


BERC-Luso

Online meeting with the trainees from São Tomé and Príncipe

September 2020

The coordination of BERC-Luso meets, on the 15th of September, with the team of trainees from São Tomé and Príncipe.

This meeting also has the prestigious collaboration and presence of the Minister of Health of São Tomé and Príncipe, Mr. Edgar Neves.

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 status of the commitment drawn up in Cape Verde.


BERC-Luso

3rd session of the Debate Forum - Dissemination of clinical trials

August 2020

On August 28, the 3rd session of the monthly Webinar Forum of the BERC-Luso project dedicated to the "Dissemination of Clinical Trials" is held by CEIC.

During the presentation of the theme, the importance of disseminating in information from research in general and clinical trials in particular is presented. The dissemination of information from clinical trials in the form of posters, leaflets or brochures, for example, contributes to the knowledge of clinical trials by patients and  should be made available in healthcare units and should not be understood as advertising.

The common understanding, and the CEIC in particular, is that recruitment to clinical trials should be a clinical act and therefore favour the recruitment of patients by the doctor on the basis of the doctor-patient relationship, free of any external influence. However, the dissemination of clinical trials allows patients free and responsible access to innovative therapies free from the possible constraints of the doctor-patient relationship, contributes to greater health literacy of the general population and patients in particular and greater transparency of research. Thus, the importance and necessity of public dissemination of clinical research was also stressed, but shouldn’t be confused with publicity.

After the presentation, the discussion between the partners follows.


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