African-European Symposium: Challenges in Research Ethics Assessment, 13:00 – 18:00 CET, May 25th, 2021.

The symposium,  organised by The Embassy of Good Science, in collaboration with EURECBERC-LusoAfriEthique, and LiberHetica, aims to facilitate the sharing of experiences and perspectives on research ethics assessment challenges between African and European experts. The symposium is organized into four sessions in which experts will present on challenges and solutions related to the theme of their session. A panel discussion will follow the speaker presentations https://bit.ly/3tqlS9H.

The symposium will be live streamed here (no registration required):

https://zoom.us/j/92564963152?pwd=M3JnYWNYNEU2eVYrR3NrUG5vSWR1QT09

Passcode: sN6yzc

Biomedical Ethics and Regulatory Capacity Building: International Dialogues

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

The LiberHetica and BERC-Luso 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, Guinea Bissau, Mozambique and Cape-Verde) and 2 European countries (U.K. and Portugal).

The Congolese National Medicines Regulatory Authority (DPM) with WHO to guarantee the development and circulation of safe and effective drugs, by implementing the Global Benchmarking Tool (GBT)

As part of the strengthening of health systems and in particular the regulation of drugs and health products within the Africlinique project, the headquarters of the World Health Organization (WHO), the WHO Regional Office for Africa (AFRO), and the WHO Country Office (PO) in the Republic of Congo provided technical assistance to support the Directorate of Pharmacy and Medicine (DPM) of Congo from February 15 to 19 2021 in Brazzaville (Republic of Congo).

The Global Benchmarking Tool (GBT) integrates the Maturity Level (ML) of the various drug regulatory functions in a computerized platform that facilitates its use and the ranking of maturity indicators. This self-assessment has enabled several countries in the sub-region to identify their ML as well as to put in place institutional development plans (IDPs) in order to access a ML which guarantees safety,  quality and effectiveness of drugs in development and in circulation.

Click here to for news release in English.

SEARCH project kick-off meeting

After months of intense preparation, the SEARCH (SouthErn Africa Regulatory for Clinical researcH) will have its project kick-off meeting. The Partners from all countries of SEARCH Consortium (Mozambique, Botswana, Eswatini, Lesotho and UK), together with the invited relevant stakeholders, will meet on February 18, 2021. Click here for more information: https://bit.ly/3jEUzFg
This EDCTP-funded project is aimed at increasing the regulatory capacities for review of clinical trials in Southern Africa by establishing European-African collaborations that facilitates implementation of efficient processes, harmonized procedures, standardized guidelines and effective training programs.

Second European-African training for the Congolese team on “SARS-CoV-2 detection by ApoH enzyme”

As part of the implementation of ITAIL-COVID-19 project funded by the European Development Countries Partnership for Clinical Trials (EDCTP) and coordinated by the Congolese Foundation for Medical Research (FCRM), the Congolose team of this project participated on January 14, 2021 in the second online practical training on “SARS-CoV-2 detection by the ApoH“. Supervised by the French Research Institute for Development (IRD), this second practical training allowed participants to become familiar with this ultrasensitive virus detection technique. The training on this new technology was carried out by Dr. Carolyn Thibal (ApoH-Technologies) and Professor Francisco Veas, from IRD Montpellier – France. This technique will detect newly infected people with very low viral load, not possible to be detected with conventional methods, including classic RT-PCR. This ApoH detection will be very helpful for monitoring health workers who are at the forefront of the fight against the pandemic. The first training was held on September 2020.

 

INTEGRATION

“This project will improve malaria prevention strategies for both children, pregnant women and families as a whole as the study is being conducted in families which will raise awareness of malaria prevention. Furthermore, the proposed strategy can reduce the high risk estimated by the WHO that deaths from malaria double as a result of the interruption of interventions due to the Covid-19 pandemic “, are the words of the evaluators appointed by the European Commission (EDCTP) to examine the INTEGRATION project proposal.
Trusting in a positive outcome, the consortium of African and European researchers who developed the project proposal (Mali, Burkina Faso, France, U.K. and Italy) is now committed to providing further information and clarification to the assessors, who will complete the evaluation in January 2021.

From 2003 at the forefront of supporting Sub-Saharan Africa’s response to poverty-related infectious diseases, EDCTP plays a key role also in the African response to Covid-19

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public-public partnership between countries in Europe and sub-Saharan Africa, supported by the European Union, which since 2003 has been accelerating the clinical development of new or improved medicines for the identification, treatment and prevention of poverty-related infectious diseases, is also at the forefront of supporting Sub-Saharan Africa’s response to COVID-19 https://bit.ly/2TDonGd idー19

INTEGRATION, an intervention research to protect pregnant women from malaria

Pregnant women, babies and children under 5 years of age are the most vulnerable to malaria. In 2018, around 11 million pregnant women and 24 million children got malaria. Furthermore, the WHO estimates that due to Covid-19 there will be disruptions in the fragile national health systems that could lead to a doubling of malaria mortality this year, from 400,000 to about 800,000 deaths, more than those from Covid-19 itself.

INTEGRATION project is an intervention that strategically integrates malaria prevention treatments for pregnant women and children to change African national health prevention policies and protect millions of pregnant women from malaria every year.

INTEGRATION project has been developed by a consortium of universities, research institutes and NGO from 2 African countries (Burkina Faso and Mali) and 3 European countries (France, England and Italy), which submitted this research project to the European Commission (EDCTP).

Donne in gravidanza, neonati e bambini sotto i 5 anni di età sono i più vulnerabili alla malaria. Nel 2018, circa 11 milioni di donne in gravidanza e 24 milioni di bambini si sono ammalati di malaria. Inoltre, l’OMS stima che a causa del Covid-19 ci saranno disfunzioni nei fragili sistemi sanitari africani che potrebbero portare quest’anno a un duplicarsi della mortalità per malaria, passando da 400.000 a circa 800.000 morti, ben di più di quelli causati dal Covid-19 stesso.

INTEGRATION è un intervento che integra strategicamente i trattamenti di prevenzione della malaria per donne in gravidanza e bambini, in modo da potenzialmente cambiare le politiche di prevenzione sanitaria in Africa e proteggere dalla malaria per milioni di donne in gravidanza ogni anno.

INTEGRATION è nato da un consorzio di università, istituti di ricerca e ONG di 2 paesi africani (Burkina Faso e Mali) e 3 paesi europei (Francia, Inghilterra e Italia), che hanno presentato questo progetto al bando di ricerca alla Commissione Europea (EDCTP).

SUPER

The SUPER project will provide capacity building at the regulatory and ethics level for National Regulatory Authority, National and Institutional Ethics Committees, with the ultimate goal to strengthen an environement favourable for the clinical research addressing the burden of diseases in the Eastern African region. The project is coordinated by EACCR, the Network of Excellence in clinical research for Eastern African region, lead by Dr. Pontiano Kaleebu.

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