The BREEDIME project main objective is to strengthen regulatory affairs in area of ethical review processes, clinical trials control, assessment, and post marketing evaluation of therapeutics, vaccines, diagnostics, and critical medical devices
The “Building Resilient Research Ethics, Diagnostics and Medicines regulatory capacity during routine and public health emergency periods” by acronym “BREEDIME” Project is 36 months project involving 9 consortium members namely;
To strengthen regulatory affairs in area of ethical review processes, clinical trials control, assessment, and post marketing evaluation of therapeutics, vaccines, diagnostics, and critical medical devices
The BREEDIME Project has eight (8) work packages and each is led by different consortium institution as described below;
WPs | WP Title | Lead Institution |
---|---|---|
1 | Therapeutic or vaccine trial protocol evaluation during public health emergency | Rwanda FDA |
2 | In-vitro diagnostics and critical devices | TMDA |
3 | Health data management during emergency period | NIMR |
4 | Post marketing surveillance and appraisal | ZFDA |
5 | Training | MUHAS |
6 | Scientific leadership and networking | TMDA |
7 | Project management and coordination | KI |
8 | Communication and dissemination | KCRI-GFS KCMC |
Project Title: | Building resilient research ethics, Diagnostics, and medicines regulatory capacity during routine and public health emergency periods with acronym of “BREEDIME”. |
Acronym: BREEDIME
Project start date: 01st June, 2023
Duration: 36 months
Collaborative Institutions: | Tanzania Medicines and Medical Devices Authority (TMDA), Karolinska Institutet (KI), Zanzibar Food and Drug Agency (ZFDA), BREEDIME Rwanda Food and Drugs Authority (Rwanda FDA), Kilimanjaro Clinical Research Institute (KCRI), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Health and Research Institute (ZAHRI) and The University of St. Andrews (UStAn). |
Grant amount: EUR 599 637.50
Coordinated by: KAROLINSKA INSTITUTET
Funding Organization: EDCTP
The following deliverables have been completed;
Work Package No | Deliverable No | Deliverable Name | Description | Lead Beneficiary | Due Date | Status |
---|---|---|---|---|---|---|
WP1 | D1.1 | Guidance/algorithm in response to evaluation | To develop Guidance/algorithm to be followed in response to evaluation of therapeutic and vaccines trials protocol and comments during an emergency outbreak | Rwanda FDA | 31 Oct 2023 | Completed |
WP1 | D1.2 | Guidelines and SOP for evaluation | Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency | Rwanda FDA | 31 Jan 2024 | Completed |
WP2 | D2.1 | Baseline assessment report | The baseline assessment for evaluation of diagnostics and critical medical devices will be conducted and report should be prepared | NIMR | 30 Nov 2023 | Completed |
WP2 | D2.2 | Developing guidance documents for conducting performance evaluation | Developing guidance documents for applicants and manufacturers on requirements for conducting a performance evaluation of diagnostic test kits | TMDA | 31 May 2024 | Completed |
WP2 | D2.4 | Developing Protocols for conducting performance verification studies | Developing specific protocols for conducting performance verification studies for selected diagnostics test kits used for testing Covid-19, HIV, Hepatitis, Syphilis, TB and Malaria and developing other working tools such as SOPs, flow charts | TMDA | 31 May 2024 | Completed |
WP3 | D3.2 | Data Management Plan | Data management plan will be developed | NIMR | 30 Nov 2023 | Completed |
WP4 | D4.1 | Post-marketing protocol and plan developed | Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market | ZFDA | 31 Mar 2024 | Completed |
WP5 | D5.1 | Training Needs Assessment | Training needs assessment for both therapeutic and vaccines protocol evaluation, and for performance evaluation of in-vitro diagnostics and critical medical devices will be conducted for staff from TMDA, ZFDA, Rwanda FDA, NIMR and ZAHRI | MUHAS | 31 Mar 2024 | Completed |
WP5 | D5.2 | Customization of short ethics course for Rwanda | Short ethics course will be customized for Rwanda FDA | GSF KCMC | 30 Sep 2024 | Completed |
WP8 | D8.2 | Launching of the project | The project will be launched to create awareness on its objectives and other issues pertaining to the project | GSF KCMC | 31 Jul 2023 | Completed |
WP8 | D8.4 | Website of the project | Website of the project will established | TMDA | 31 Aug 2023 | Completed |
WP8 | D8.5 | Exploitation and Dissemination plan | Exploitation and dissemination plan developed | GSF KCMC | 30 Nov 2023 | Completed |
Work Package No | Deliverable No | Deliverable Name | Description | Lead Beneficiary | Due Date |
---|---|---|---|---|---|
WP1 | D1.1 | Guidance/algorithm in response to evaluation | To develop Guidance/algorithm to be followed in response to evaluation of therapeutic and vaccines trials protocol and comments during an emergency outbreak | Rwanda FDA | 31 Oct 2023 |
WP1 | D1.2 | Guidelines and SOP for evaluation | Guidelines and SOP for the evaluation of therapeutic and vaccine trials in a period of public health emergency | Rwanda FDA | 31 Jan 2024 |
WP1 | D1.3 | Joint evaluation of clinical trials | A joint evaluation of clinical trials applications which are Completed to the Regulatory Authority and Ethics Committee will be conducted. Joint evaluation will be conducted by a group of assessors from TMDA, ZFDA, Rwanda FDA, NIMR, ZAHRI. Conducting joint evaluation of clinical trial protocols will reduce waiting time | TMDA | 31 May 2025 |
WP1 | D1.4 | Post-approval Joint inspections of clinical trials | Conducting post-approval joint inspections of clinical trials to ensure they are conducted ethically. Joint inspection between TMDA, ZFDA, Rwanda FDA, ZAHRI and NIMR will be done. The TMDA and NIMR twining team of inspectors will be created and assigned for a site inspection of the approved clinical trials. The inspection will be conducted at 18 and 30 months. The inspections will also be done in other consortium countries. | TMDA | 30 Nov 2025 |
WP2 | D2.1 | Baseline assessment report | The baseline assessment for evaluation of diagnostics and critical medical devices will be conducted and report should be prepared | NIMR | 30 Nov 2023 |
WP2 | D2.2 | Developing guidance documents for conducting performance evaluation | Developing guidance documents for applicants and manufacturers on requirements for conducting a performance evaluation of diagnostic test kits | TMDA | 31 May 2024 |
WP2 | D2.3 | Performance evaluation of diagnostics and critical medical devices | Conducting performance evaluation of diagnostics and critical medical devices. The performance evaluation verification will be conducted by assessors | TMDA | 31 May 2025 |
WP2 | D2.4 | Developing Protocols for conducting performance verification studies | Developing specific protocols for conducting performance verification studies for selected diagnostics test kits used for testing Covid-19, HIV, Hepatitis, Syphilis, TB and Malaria and developing other working tools such as SOPs, flow charts | TMDA | 31 May 2024 |
WP3 | D3.1 | Establishing a regulatory framework on health data and material sharing during the emergency periods | A regulatory framework will be established on health data and material sharing during the emergency periods. Different guidelines will be developed and these will include guide for data collection tools (manual and electronic), data storage, accessing archived data for research, sharing data in-country and outside country. This will improve ethics requirements for health data and material access during emergency periods | NIMR | 30 Sep 2025 |
WP3 | D3.2 | Data Management Plan | Data management plan will be developed | NIMR | 30 Nov 2023 |
WP3 | D3.3 | Updated Data Management Plan | Update the Data Management Plan as needed during the project's progress | NIMR | 30 Nov 2024 |
WP4 | D4.1 | Post-marketing protocol and plan developed | Post-marketing protocol and plan developed based on risk assessment of the medical products circulating on the market | ZFDA | 31 Mar 2024 |
WP4 | D4.2 | Sample collections and perform product information reviews | Collecting samples from the market based on the approved sampling plan and product information review (PIR) will be conducted as per the established protocol. The results of Products information review (PIR) will be disseminated during stakeholders meeting Regulatory actions will be taken for those who will not comply with regulations | ZFDA | 31 Jan 2025 |
WP5 | D5.1 | Training Needs Assessment | Training needs assessment for both therapeutic and vaccines protocol evaluation, and for performance evaluation of in-vitro diagnostics and critical medical devices will be conducted for staff from TMDA, ZFDA, Rwanda FDA, NIMR and ZAHRI | MUHAS | 31 Mar 2024 |
WP5 | D5.2 | Customization of short ethics course for Rwanda | Short ethics course will be customized for Rwanda FDA | GSF KCMC | 30 Sep 2024 |
WP5 | D5.3 | Preparation of training curriculum and materials for assessors | Preparation of training curriculum and materials for assessors will be done | MUHAS | 30 Sep 2024 |
WP5 | D5.4 | Training of clinical trial assessors on in-vitro and medical devices CTs evaluation | Training of clinical trial assessors on in-vitro diagnostics and medical device clinical trial evaluation. The TMDA-MUHAS RCORE will be strengthened by conducting different trainings for reviewers, assessors and inspectors on evaluation and inspection of new trials of both emerging and re-emerging diseases in the emergency period. | MUHAS | 30 Nov 2025 |
WP5 | D5.5 | Training on rapid evaluation of therapeutic or vaccine trial | Training on rapid evaluation of therapeutic or vaccine trial protocol during a public health emergency. Training and Technical support will be provided to the responsible personnel on clinical trials evaluation in consortium African countries for them to improve and respond fast in the evaluation of the protocol during emergencies. | MUHAS | 30 Nov 2025 |
WP6 | D6.1 | Regulatory Capacity building of other SSA countries, and Sharing Scientific experience within consortium countries | Regulatory capacity building, Sharing scientific experience within the consortium countries. Benchmarking and mentoring of SSA countries will be conducted. | TMDA | 28 Feb 2026 |
WP7 | D7.1 | Monitoring and Evaluation of the project | Monitoring and evaluation of the project will be done to ensure its smooth implementation. Resources of the project will be controlled to achieve specific project goals | KI | 31 May 2026 |
WP8 | D8.1 | Awareness creation on the existence of the Project | Awareness creation on the existence of the BREEDIME project by using different forum and social media | GSF KCMC | 31 May 2026 |
WP8 | D8.2 | Launching of the project | The project will be launched to create awareness on its objectives and other issues pertaining to the project | GSF KCMC | 31 Jul 2023 |
WP8 | D8.3 | Dissemination of reports to all stakeholders | Dissemination of the reports to relevant stakeholders by conducting Stakeholders' forum annual project meetings including preparations for policy brief. The meeting will be convened to disseminate different information about the project and its progress and outcome. | GSF KCMC | 31 May 2026 |
WP8 | D8.4 | Website of the project | Website of the project will established | TMDA | 31 Aug 2023 |
WP8 | D8.5 | Exploitation and Dissemination plan | Exploitation and dissemination plan developed | GSF KCMC | 30 Nov 2023 |
WP8 | D8.6 | Updated Exploitation and Dissemination Plan | Update the Exploitation and Dissemination Plan as needed during project's progress | GSF KCMC | 30 Nov 2024 |