The LiberHetica and BERC-Luso consortia meet on the 26th March 2021 to discuss about Biomedical Ethics and Regulatory Capacity Building in Sub-Saharan African countries.

The BERC-Luso and LiberHetica are two projects funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) aimed at strenghting ethics and regulatory capacities for clinical trials by partnerships between African and European countries, and involving 5 Sub-Saharan African countries (Liberia, Angola, Cape-Verde, Guinea Bissau, Sao Tome and Mozambique) and two European countries (U.K. and Portugal).

In addition to the partner countries, Ms. Maria Hermínia Cabral and Mr. João De Almeida Pedro from the Calouste Gulbenkian Foundation, the institution that supports BERC-Luso, as well as Ms. Mariama Pinto, Third Secretary, Head of the Health and Social Affairs Department of the Embassy of Guinea-Bissau in Portugal, are also present.

The session is moderated by Professor Maria do Céu Patrão Neves and Master Jemee Tegli.

In this webinar the partner countries present the latest legislative and institutional. developments.

We present a brief summary of the changes to date.

Angola

Ethical Regulation:

• Revision of the proposed Law on Clinical and Biomedical Research, after the opinion of MINSA's Legal Office;
• Creation of the DNME/INIS technical group to create standards for research on medicinal plants with potential use in the treatment of covid-19

Legislative framework:

•  The approval of the proposed Presidential Decree on pharmacovigilance is awaited and has already been sent to the MINSA;
• Awaiting approval of the proposed Medicines Law, already submitted to the MINSA;
• Approval of the proposal for a Presidential Decree that creates the Medicines Regulatory Authority is awaited
• Publication in “Diário da República” of the Regulation for the Registration of Medicines in Angola, in accordance with Presidential Decree No. 315/20 of 17^th December.

Cape Verde

• Discussion between ERIS and CNEPS of strategies to promote, with the Ministry of Health and Social Security, the drafting of a Clinical Research law;
• At this moment, the creation of a working group is pending

Legislative framework:

• The drafting of the Clinical Research Law is pending.

Guinea Bissau

• The Possibility of constituting a working group for the approval of the law on research and health.
• The Possibility of Legalizing the National Institute of Public Health (INASA)

 São Tome and Príncipe

• The Minister of Health approved the proposal for the establishment of a Pharmaceutical Regulatory Authority
• The proposal was submitted to the Council of Ministers and also approved;
• It is currently under consideration in the National Assembly for its approval.

On the 11^th of February takes place the session "Legislative and Institutional Impact of BERC-Luso in the PALOP", at 05:00 pm (GMT), through the zoom platform.

In this webinar the speakers present the latest legislative and institutional developments in the respective partner countries.

Ms. Joana Morais (INIS - Angola), Ms. Ester Oliveira (ERIS - Cape Verde), Mr. Mouhammed Ahmed (INASA - Guinea-Bissau), Mr. Jeryson Ramos and Ms.  Vânia Castro (MS - Sao Tome and Principe participate in the event.

The BERC-Luso Coordination meets, on 11th January, with the professionals from  Cape Ver through  Microsoft Teams platform.

Ms. Maria de Lourdes Monteiro, Ms. Lenira Centeio, Ms. Ester Oliveira and Ms. Crisolita Duarte 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. In this case stand out the webinars and the internship at INFARMED and CEIC which due to the circumstances didn´t take place in September as expected.   

The BERC-Luso Coordination meets, on 8th January, with the professionals from Guinea-Bissau through  Microsoft Teams platform.

Ms. Marirelene D’Alva and Mr.Mouhammed Ahmed  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. In this case stand out the webinars and the internship at INFARMED and CEIC which due to the circumstances didn´t take place in September as expected.   

The BERC-Luso Coordination meets, on 7th January, with the professionals from Sao Tome and Principe through  Microsoft Teams platform.

Ms. Semôa Espírito Santo, Ms. Vânia Castro, Ms. Isaulina Barreto and Mr. Jeryson Ramos 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. In this case stand out the webinars and the internship at INFARMED and CEIC which due to the circumstances didn´t take place in September as expected.   

The BERC-Luso Coordination meets, on 6th January, with the professionals from Mozambique through  Microsoft Teams platform.

Ms. Telma Chiucamba participates 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. In this case stand out the webinars and the internship at INFARMED and CEIC which due to the circumstances didn´t take place in September as expected.   

 

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.   

The BERC-Luso Project Coordinator, Professor Maria do Céu Patrão Neves, meets on Wednesday, 9^th December, with Mr. Jemee Tegli, LiberHetica Project Coordinator, Ms. Gloria Manson, Coordinator of the National Research Ethics Board (NREB) in Liberia and Mr. Dario Scaramuzzi, Pro-bono Partnership & Capacity Development Manager.
 
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.

On 4^th December, a webinar dedicated, in particular, to the case study of SUSAR, the target of notification by the promoter to the regulatory authority under the guidance of Mrs. Leonor Nogueira Guerra. The concepts and definitions of pharmacovigilance essential in the context of clinical research are recalled, a brief presentation of the structure and organisation of the safety monitoring of clinical trials at European level is recalled and concrete clinical cases of suspected serious and unexpected reactions occurred in the context of clinical trials are subsequently analysed. Finally, some practical suggestions for organizing and managing information related to this type of reactions are presented, as well as useful links with additional information on the subject.