The pandemic situation that the world is going through has led to profound changes in all categories of individual and social activity, forcing a constant effort to adapt to new realities and respond to current needs. The BERC-Luso also follows this dynamic. In this context, BERC-Luso, faithful to its design of ethical and regulatory training in the field of biomedicine and wanting to contribute to the better response of partners to the extraordinary demands of pandemic times, organizes a thematic Debates Forum, under the common name “ Best practices in pandemic times ”.

The webinar will contain a brief thematic introduction by the person in charge of the session in question, followed by debate between all participants.

Program:

May 15(12 pm- 13pm /Lisbon)

–Community masks: manufacture, access and use -
Mr. Jorge Batista and Professor Patrão Neves

May 22 (12 pm-13 pm /Lisbon)

– Informed consent in pandemic time: clinical assistance and biomedical research -
Professor Patrão Neves and  Professor Alexandra Ribeiro

May 29 (12 pm-13pm/Lisboa)

– Clinical research: pandemic-time procedures -
Mr. Rui Ivo and Professor Alexandra Ribeiro

June 5 (12pm-13pm/Lisbon)

– Clinical research and innovation -
Professor Ana Paula Martins and Professor Helder Mota Filipe

On May 15, the first webinar "Best International Practices in Pandemic Time" takes place, with the theme "Community masks: manufacture, access and use". The session takes place with the participation of 15 trainees of the BERC-Luso Project, and consists of a short intervention by Professor Maria do Ceu Patrão Neves, coordinator of BERC-Luso and Mr. Jorge Batista, Executive Manager of the Project BERC-Luso Project, on the use of masks in the context of the COVID-19 pandemic, followed by a debate that will count with all the participants present at the event. The intervention focuses on the differences between the numerous types of protective masks, medical devices, personal protective equipment and textile articles, their usage and indications. Subsequently, information on community masks or social masks is then presented, including their correct use, certification and widespread use in the population, including resources available in Portuguese from the Directorate-General for Health of Portugal and INFARMED.

Participants from each country can share their national experiences, regarding the national certification of these articles, the policies implemented in each country, as well as access to these products.

Finally, and responding to a previous request from the participants, a set of resources on the role of pharmacists played in the COVID-19 pandemic is shared, disseminating the Resources in Portuguese of the International Pharmaceutical Federation (FIP), consisting of health promotion material, intervention protocols and evidence material on SARS-CoV-2 infection.

The BERC-Luso coordination meets on the 7th of May 2020 with the trainees of the Republic of Angola, via electronic platform, with the presence of Ms. Jocelyne Vasconcelos, Ms. Isabel Malungue and Mr. Adelino Quiteque.

The goal of the meeting is to listen to the necessities of the partner countries in this phase of combat to the new coronavírus, maintaining a link between partner countries and the BERC-Luso project.

The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, maintaining a link between partner countries and the BERC-Luso project, and to promote webinars aiming at discussing relevant topics.

The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Guinea Bissau, via electronic platform, with the presence of Ms. Zeferina Costa, Mr. Mouhammed Ahmed and Mr. Cesário Martins.

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 maintaining contact between partner countries and the BERC-Luso project, promoting the development of thematic webinars.

The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Cape Verde, via electronic platform, with the presence of Ms. Maria de Lourdes Monteiro, Ms.  Lenira Centeio, Ms. Ester Oliveira, Ms. Sheila Monteiro and Ms. Maria do Céu Teixeira.

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 promotion of webinars aiming at discussing relevant topics to all partner countries. 

BERC-Luso coordination meets on the 5th of May 2020 with the trainees of the Democratic Republic of São Tomé e Príncipe, via electronic platform, with the presence of Mrs. Semôa Espírito Santo and Mr. Jeryson Ramos.

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 promotion of webinars aiming at discussing relevant topics to all partner countries, whilst maintaining a link of communication between countries. 

On the afternoon of the last day of work, on 22nd  February, takes place the Commitment Celebration Session of the Training Action of the BERC-Luso Project. The main objective of this session is to celebrate the commitment of all participants from BERC-Luso partner countries, in relation to the best practices in healthcare and clinical research, to be implemented in the present and in the future, formulated under the designation of the “Declaration of Commitment ”.

The Session begins with a debate moderated by Professor Helder Mota Filipe and welcoming Mr. Andreas Reis, representative of the World Health Organization (WHO)  and  Professor  Dafna Feinholz, representative of UNESCO. Participants from partner countries thus have the opportunity to clarify questions about the activities of these organizations and explore possible points of collaboration.

Subsequently, representatives of the BERC-Luso partner countries present the Declarations of Commitment: Mr. Mamba Sampaio (Angola), Mr. Victor Gomes (Guinea Bissau), Mrs. Telma Chicuamba (Mozambique), Mrs. Semôa Sousa (São Tomé and Príncipe), and by Cape Verde Mrs. Lenira Centeio, Mrs. Maria de Lourdes Monteiro and Professor Antonieta Martins. These Declarations of Commitment reflect a set of actions to be developed in the various countries, with the aim of improving the conditions and installed capacity for the development of biomedical research and clinical trials.

The trainees from all countries formally deliver to the WHO and UNESCO representatives, Mr. Andreas Reis and Professor Dafna Feinholz, respectively, a partnership proposal for support and training in the areas of ethical and regulatory review, as well as requesting support in concrete actions. The representatives of international institutions formally present to all training professionals a document containing a set of publications and teaching material, fundamental for the training of these professionals and their countries. The partnership between Angola, Cape Verde, Guinea Bissau, Mozambique, São Tomé and Príncipe, the World Health Organization and UNESCO, will allow the establishment of direct contact points with support for the continuation of training initiatives in the area of ethical and regulatory review in the various countries.

The Closing session is done by the Coordinator of BERC-Luso, Professor Maria do Céu Patrão Neves, and the Executive Project Manager, Mr. Jorge Batista.

The representative of the World Health Organization (WHO), Dr. Andreas Alois Reis, holds the session on "Ethics in Global Health", on the morning of February 22nd. Then, Professor Dafna Feinholz, representative of UNESCO, presents the session on "Bioethics and Ethics in Science and Technology". Both sessions aim to make known the action of WHO and UNESCO in the field of ethical and regulatory training in the domain of care and biomedical research, thus presenting the main programs implemented by these institutions in these areas.

The formal sitting of the Formation of the BERC-Luso  Project  takes  place  on  the  afternoon  of  21^st  February. The session has the intervention of the Coordinator of BERC-Luso, Professor  M. Patrão Neves; the intervention of a representative of the group  of  trainees from each of the partner countries of the Project  –  Mr. Adelino Quiteque (Angola), Mrs. Marilene D'Alva (Guinea Bissau),  Mrs. Telma Chicuamba (Mozambique),  Mrs. Camila Barros (S. Tomé e Príncipe )  and  Mrs. Maria de Lourdes Monteiro (Cape Verde) – and intervention of His Excellency  the Minister of Health and Social Security of Cape Verde, Mr. Arlindo do Rosário.

The trainees present the Contextualization Report on Biomedical Research and Clinical Trials in each of their countries, showing the initiatives developed in regulatory and ethical matters.

His Excellency Minister of Health and Social Security of Cape Verde, Mr. Arlindo do Rosário congratulates the BERC-Luso Project for its dimension and capacity to bring together the PALOP with national and international institutions, and reinforces the commitment made to the development of attractive conditions for the establishment of Clinical Trials in Cape Verde.

After the end of the session, a Solemn Dinner is followed with the presence of institutional guests at the Hotel Oasis Atlântico Praiamar.

The representative of the Pharmaceutical Society, Professor Helder Mota Filipe,  and the representative of INFARMED, Mrs. Helena Beaumont promote training with the theme  "Regulation of Clinical Trials" on February 21^st .

This training promotes access to a broad knowledge of medicines regulation, including national and European regulatory framework. The regulatory framework and best clinical and manufacturing practices are contextualized. The module focuses particularly on guidelines for the conduct and assessment procedures of clinical trials, thus ensuring the theoretical basis for the intensive internship that takes place in September 2020.