During the first reporting period, CAPACITY 2023 achieved significant scientific, technical, and capacity-building milestones.
Key achievements include:
Evidence generation and regulatory development
- Completed the first national study assessing knowledge, perceptions, and readiness for gene therapy in Uganda.
- Established a multidisciplinary task force of bioethicists, epidemiologists, and gene therapy experts to draft Uganda’s first regulatory guidelines for gene therapy clinical trials.
These outputs form the scientific foundation for future regulatory frameworks.
Capacity strengthening through training and placements
- Thirty-four (34) participants completed a specialised course on EU regulatory frameworks for clinical trials and advanced therapies.
- Six (6) regulatory and academic professionals participated in two-week placements at leading Portuguese institutions, gaining practical experience in regulatory review, ethics oversight, GMP processes, and clinical trial operations.
- Knowledge acquired was shared widely, reinforcing institutional learning.
Scientific capacity building and knowledge exchange
- Hosted the First Cell and Gene Therapy Symposium in Uganda, with more than 800 participants covering scientific, ethical, manufacturing, and clinical dimensions of gene therapy.
- Launched a Gene Therapy Webinar Series providing regular technical training to more than 1500 participants, mainly from East Africa but also from other countries and continents.
- Developed comprehensive Information, Education and Communication materials, targeting professionals and the general population.
- Designed a multidisciplinary Gene Therapy Course (11 modules), which has been submitted for accreditation.
Strengthening pharmacovigilance systems
- Conducted the first systematic baseline assessment of pharmacovigilance practices in clinical trials in Uganda, identifying gaps and proposing evidence-based improvements.
- Twelve (12) consortium members completed advanced Eu2P - pharmacovigilance training.
- Recruited a dedicated Safety Officer to reinforce institutional capacity.
Project management
CAPACITY 2023 successfully delivered all 18 planned Deliverables and 17 Milestones, with only minor delays. This reflects strong scientific coordination, supporting the timely execution of all technical activities, efficient and robust expert-consultation mechanisms, and effective data management structures.
