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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.


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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.


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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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2nd session of the Discussion Forum - Practical aspects related to the implementation of the experimental medicines circuit in clinical trial hospitals

July 2020

On the 24th of July , the second session of the Online Discussion Forum "Clinical Research: Principles and Procedures" is held under the theme " Practical aspects related to the implementation of the experimental medicines circuit in Clinical Trial hospitals” with the intervention of Mrs. Helena Farinha, National Director of the Portuguese Pharmaceutical Society.

This presentation focused on the practical aspects of the implementation of the experimental medicine circuit at the hospital.

The initial framework addresses the types of studies, the phases of clinical trials (EC) and the different designs according to the objectives and methodologies defined and the documents with the greatest impact were pointed out on the  EC (Nuremberg Code; Declaration of Helsinki; Belmont Report), specifically in the development of legislation on the regulation of clinical research (Law No. 21/2014, of April 16 - Portugal). The bodies involved for the purpose of the necessary preliminary approvals as well as all the actors in the EC (researcher, promoter, monitor and participant) are also addressed, highlighting that the EC must respect the dignity and rights of its participants above the scientific and social interests and that the participant must understand the objectives, risks, disadvantages and conditions of the clinical study, having to obtain informed consent.

The experimental medicine circuit is also  detailed (identification of the test centre, feasibility, pre-study visit; submission of the study to the competent authorities, initial visit conduct of the trial and closing visit)  and the role of hospital pharmacists in the execution of EC is evidenced ("... responsible for the receipt, storage, preparation, dispensation, collection and return or destruction of the medicinal product, having the duty to draw up a descriptive document of the experimental medicinal product circuit containing elements relating to the receipt, storage, dispensation and administration of the investigational medicinal product"). Also within the scope of this circuit, the conduct of the EC in the Pharmaceutical Services presents several stages, which  are  detailed, namely: 1) appointment of the pharmacist responsible; 2) confirmation of the conditions of realization; 3) receipt of the protocol and verification of documentation; 4) beginning of study meeting; 5) preparation of the test documentation; 6) reception and verification of the experimental medicinal product (and comparators/adjuvants, where applicable), 7) storage (temperature and humidity control); 8) medical prescription; 9) validation of the medical prescription; 10) preparation and dispensation of experimental medicine; 11) return of the experimental drug; and 12) closure of the EC.

The EC are very important because they enable the development of new medicines and therapies, representing opportunities for patients to access innovative treatments. Therefore, strict compliance with the protocols and the guarantee of the appropriate conditions for their implementation are necessary. The creation of process and performance indicators thus becomes a need and quality assurance.

The management and monitoring of the experimental medicinal product circuit is essential for the safety and quality of the execution of the test. This responsibility rests with the pharmacist, being unequivocally explained and recognized in national legislation.


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