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 progress have been made;
WP # | Deliverable # | Deliverable Name | Lead | Due Date (M) | Actual Date | Remarks |
---|---|---|---|---|---|---|
WP 8 | D8.2 | Launching of the project | KCRI-GSF KCMC | 5 (31stJuly, 2023) | 4th August, 2023 |
WP # | Deliverable # | Deliverable Name | Lead | Due Date (M) | ||
---|---|---|---|---|---|---|
WP 1 | D1.1 | Guidance/algorithm in response to evaluation | Rwanda FDA |
5
|
||
D1.2 | Guidelines and SOP for evaluation | Rwanda FDA |
8
|
|||
D1.3 | Joint evaluation of clinical trials | TMDA |
24
|
|||
D1.4 | Post-approval Joint inspections of clinical trials | TMDA |
30
|
|||
WP 2 | D2.1 | Baseline assessment report | NIMR |
6
|
||
D2.2 | Developing guidance documents for conducting performance evaluation | TMDA |
12
|
|||
D2.3 | Performance evaluation of diagnostics and critical medical devices | TMDA |
24
|
|||
D2.4 | Developing Protocols for conducting performance verification studies | TMDA |
12
|
|||
WP 3 | D3.1 | Establishing a regulatory framework on health data and material sharing during the emergency periods | NIMR |
28
|
||
3.2 | Data Managment Plan | NIMR |
6
|
|||
WP 4 | 4.1 | Post-marketing protocol and plan developed | ZFDA |
10
|
||
4.2 | Sample collections and perform product information reviews | ZFDA |
20
|
|||
WP 5 | D5.1 | Training Needs Assessment | MUHAS |
10
|
||
D5.2 | Customization of short ethics course for Rwanda | KCRI - GSF |
16
|
|||
D5.3 | Preparation of training curriculum and materials for assessors | MUHAS |
16
|
|||
D5.4 | Training of clinical trial assessors on in-vitro and medical devices CTs evaluation | MUHAS |
30
|
|||
D5.5 | Training on rapid evaluation of therapeutic or vaccine trial | MUHAS |
30
|
|||
WP 6 | D6.1 | Regulatory Capacity building of other SSA countries, and Sharing Scientific experience within consortium countries | TMDA |
33
|
||
WP 7 | D7.1 | Monitoring and Evaluation of the project | KI |
36
|
||
WP 8 | D8.1 | Awareness creation on the existence of the Project | KCRI-GSF KCMC |
36
|
||
D8.2 | Launching of the project | KCRI-GSF KCMC |
|
|||
D8.3 | Dissemination of reports to all stakeholders | KCRI-GSF KCMC |
36
|
|||
D8.4 | Website of the project | TMDA |
|
|||
D8.5 | Exploitation and Dissemination plan | KCRI-GSF KCMC |
6
|