Online meeting with the trainees from Angola
The BERC-Luso Coordination meets, on 5th January, with the professionals from Angola through Microsoft Teams platform.
Mr. Adelino Quiteque, Ms. Ilda Jeremias, Ms Jocelyne Vasconcelos and Mr. Sampaio Francisco participate in the meeting.
The main goal of this meeting to take stock of the activities carried out in the last year, the challenges that arise in 2021 and the activities that will be carried out and adapted in the face of the COVID-19 pandemic. Among them stand out the webinars and the internship at INFARMED and CEIC which due to the circumstances didn´t take place in September as expected.
BERC-Luso meets with LiberHetica Project
The main goal of this meeting is to introduce each of the projects by the respective coordinators and it’s also considered the possibility of organising a meeting between all the partners of the two projects, through the zoom platform.
Webinar on Pharmacovigilance in Clinical Trials: Case Study
BERC-Luso meets with LiberHetica Project
The Coordinator of BERC-Luso Project, Professor Maria do Céu Patrão Neves, meets on Wednesday, 24th November, with Mr. Dario Scaramuzzi, Pro-bono Partnership & Capacity Development Manager and representative of the LiberHetica Project. This project, like BERC-Luso, aims to increase the ethics capacity of oversight for clinical trials in african institutions, in this case in Liberia, and is also financed by EDCTP.
This meeting, by zoom, has as main goal to explore modalities of articulation between the two projects, as well as the sharing of experiences for future collaboration.
Webinar “Monitoring of clinical trials“
On the 20th of November, the session "Monitoring of Clinical Trials" is attended by Professor Maria Alexandra Ribeiro, Interim President of the National Ethics Committee for Clinical Research (CEIC) and Mrs. Maria Pais, Master in Regulation and Evaluation of Medicine and Health Products from the Faculty of Pharmacy (University of Lisbon).
In a first phase, the procedures of the CEIC in the clinical trials, as well as their legal framework are addressed and in a second part the definition of "monitoring" and the main objectives of the clinical trial are presented; the qualifications of the promoter, the selection process of the monitors and additionally, some of the responsibilities of the monitor are introduced, according to the GUIDELINE ICH-Good Clinical Practices E6 (R2).
Finally, the most general aspects of the various types of monitoring visits with regard to the objectives of each visit and the procedures to be carried out in each type are addressed.
BERC-Luso and LiberHetica meet by zoom
On the 13rd of November, the BERC-Luso project is disseminated in the European context, at the level of the annual meeting of the European Network of Research Ethics Committees (EUREC), by Professor Maria Alexandra Ribeiro, interim President of the National Ethics Committee for Clinical Research (CEIC), representing Portugal and a member of the board of this Network.
EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level. The network promotes capacity building and assistance for local RECs to cooperate in the EU European Research Area. As an umbrella organization the network interlinks European RECs with other bodies relevant in the field of research involving human participants like the European Commission's ethical review system and the European Medical Association (EMA). In the context of the expansion of EUREC's scope of activities outside Europe, this Network seeks to establish new points of contact with China and Africa. In this context, the BERC-Luso project and the LiberHetica project were disclosed.
The LiberHetica project aims to increase the ethics capacity of oversight for clinical trials in Liberia by establishing European-African collaborations that facilitates implementation of efficient processes, harmonized procedures, standardized guidelines and educative training programs.
The articulation of BERC-Luso projects with LiberHetica, EUREC and other networks at European and African level is an asset in the context of promoting berc-luso ethical and regulatory training objectives during the project, but also after its expiry.
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.
Session "Achievements and challenges of BERC-Luso in Angola and Mozambique"
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.
Session - Achievements and challenges of BERC-Luso in Cape Verde, Guinea-Bissau and Sao Tomé and Príncipe
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.
4th webinar "Good Clinical Practices in the Construction of Scientific Evidence"
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.