Presenters introduced a range of adaptive designs including sample size re-estimation, adaptive randomization, and seamless phase II/III approaches. They explained statistical planning requirements, pre-specified decision rules, and operational safeguards. Case examples showed benefits such as increased efficiency and ethical improvements, along with risks like multiplicity concerns, operational bias, and interpretability challenges. Regulators discussed the evidence needed to review adaptive protocols, including simulations and monitoring plans. The session ended with recommendations for early scientific advice and identified adaptive designs as a priority area for future AVAREF training and guidance.

The webinar presented the scientific principles of vaccine development including immunology, antigen design, and platform technologies (inactivated, live-attenuated, mRNA, etc.). Speakers explained the stages of R&D from preclinical studies to post-licensure surveillance, and highlighted key data expected by regulators at each stage. Participants reviewed immunogenicity endpoints, correlates of protection, dose selection, and common challenges in interpreting vaccine data. Examples from past vaccine dossiers illustrated evidence requirements and regulatory uncertainties. The session supported AVAREF’s mission to build technical capacity for high-quality clinical trial review.

The session explained essential components of effective post-market surveillance and evolving expectations for Risk Management Plans (RMPs). The presenter outlined common issues seen during dossier review such as incomplete safety specifications, unclear risk minimization strategies, and weak post-authorization study plans. Case examples illustrated the importance of active surveillance, risk communications, and cross-country coordination. Participants discussed practical steps to strengthen national systems, improve reporting pathways, and integrate digital safety tools. The webinar closed with recommendations for harmonized safety practices and highlighted how AVAREF can support training and guidance development.

The webinar introduced decentralized and hybrid clinical trial models, highlighting how digital tools, remote monitoring, and community-based approaches can expand access and trial participation. Presenters gave examples of DCT elements such as e-consent, tele-visits, and home-based sample collection, and discussed Africa-specific feasibility considerations. Regulatory experts examined concerns around data integrity, oversight, and participant protection. Country representatives discussed barriers related to infrastructure, connectivity, and training. The session concluded with recommendations for developing AVAREF guidance on decentralized trials and emphasized early scientific advice and harmonized regulatory expectations to support adoption.

The session provided an overview of Africa Clinical Research Networks (ACRNs) and their critical role in strengthening clinical research excellence. Presenters discussed the structure, governance, and funding models of regional research networks, emphasizing their contribution to harmonizing trial operations, improving investigator capacity, and facilitating multi-site studies. Case studies illustrated how ACRNs support faster trial initiation, enhance recruitment, and generate regionally relevant evidence. Discussions explored synergies between ACRNs and AVAREF, including alignment on regulatory expectations, preparedness for multicounty studies, and joint planning for complex clinical protocols. The webinar concluded with recommendations for integrating ACRN sites into AVAREF’s reliance and optimization activities to strengthen the continent’s clinical ecosystem.

The presenter introduced pharmacoepidemiology and its importance for evaluating real-world safety and effectiveness of medical products. Examples from LMIC settings illustrated the feasibility of cohort studies, case-control designs, and database analyses. Participants discussed data limitations in African settings, including fragmented health information systems and governance considerations. Strategies to strengthen routine data systems and leverage multi-country collaborations were explored. The session concluded with recommendations for integrating pharmacoepidemiology into regulatory decision-making and AVAREF capacity-building activities.

The AVAREF Secretariat introduced the platform’s strategic pillars and described support activities delivered to member states, including optimization missions, workshops, scientific advice, and joint reviews. Country participants shared experiences on improvements in timelines, collaboration, and technical skills following AVAREF support. Discussion centered on emerging regulatory challenges such as adaptive designs, reliance, and emergency-use processes. The session emphasized the importance of maintaining a coordinated continental network and leveraging AVAREF’s digital transformation initiatives. This webinar reinforced AVAREF’s positioning as Africa’s central mechanism for strengthening clinical trial oversight.

The presenter described multi-disciplinary review structure, including clinical, statistical, and pharmacovigilance components. Case examples demonstrated how uncertainties are managed during the review of innovative products. Participants asked about data quality assurance, timelines, interactions with sponsors, and internal coordination across review units. The session allowed African NRAs to compare and adapt best practices to their own contexts. It reinforced the value of exchanging regulatory experiences across jurisdictions and highlighted areas where AVAREF could strengthen reviewer training.

The session introduced the development of the hRVFV-4s vaccine and reviewed Phase I safety and immunogenicity results obtained from healthy adult volunteers. Presenters discussed reactogenicity profiles, seroconversion rates, dose selection, and adverse events of special interest. Participants explored considerations for expanding to African populations, including factors related to background immunity, endemic settings, and safety monitoring. Questions focused on trial feasibility, risk communication, and site preparedness. This webinar provided early scientific insight for African NRAs and NECs to prepare for future dossier submissions and scientific advice under AVAREF coordination.

The webinar examined the principles of post-market safety surveillance, including spontaneous reporting, active surveillance, signal detection, and risk minimization. The presenter discussed examples of real-world failures and successful surveillance systems. Participants explored how regulatory agencies can institutionalize post-authorization safety studies, improve reporting timeliness, and incorporate pharmacovigilance data into decision-making. Cross-country collaboration was emphasized as a key factor in improving safety systems, along with harmonizing risk management plan requirements.

This joint webinar addressed two complementary themes essential to strengthening clinical trial oversight in Africa. The first session introduced the concept of informativeness and the risks posed by uninformative trials. Trainers explained core elements—statistical power, endpoint selection, feasibility, and generalizability—and presented the Informativeness Assessment Tool as a structured method for evaluating protocol robustness during scientific advice and CTA review. Participants practiced applying the tool and discussed how it can support early regulatory dialogue and improve trial quality across countries.

The second session focused on digital transformation and provided an overview of global experiences with electronic CTA (eCTA) platforms. Presenters from the Gates Foundation and nuvoteQ shared case studies demonstrating improvements in dossier management, reviewer coordination, and transparency. Technical considerations such as interoperability, workflow harmonization, and change management were discussed. Participants also explored how AVAREF’s upcoming digital platform could incorporate eCTA functions to support joint reviews and reliance pathways.

Together, the sessions reinforced the importance of strong scientific design and efficient digital systems to enhance regulatory decision-making in Africa.

The webinar, hosted with Cochrane South Africa, provided insights into the governance and operational functioning of PACTR. Presenters outlined improvements made in trial registration, common challenges faced by sponsors, and how NRAs and NECs can use PACTR to verify compliance with registration requirements. The session examined how improved trial transparency contributes to ethical oversight, avoids duplication, and strengthens the credibility of African clinical research. Participants discussed how registry data can support systematic reviews and regulatory decision-making. The session concluded with recommendations for further harmonizing registration requirements across countries using AVAREF’s platform.

The session, led by the Medicines Control Authority of Zimbabwe, provided a detailed overview of the country’s AEFI surveillance structure, reporting channels, and data management processes. The study results showed both progress and persistent challenges in reporting completeness, timeliness, and feedback mechanisms. Presenters discussed how systematic strengthening of surveillance tools and training can improve data quality and detection of safety signals. Participants exchanged experiences from their own countries, highlighting the importance of integration with immunization programmes and cross-country collaboration. The webinar reinforced the need for coordinated vaccine safety systems across Africa and identified areas where AVAREF can support capacity building and harmonized approaches.