Conference Schedule

Registration Process for all Participants. 07:30 – 09:00 Registration SCoMRA Secretariat 09:00 – 09:05 Kenya National Anthem 09:05 – 09:10 African Union National Anthem

Introduction to the SCoMRA session, including a warm welcome to participants and presentation of objectives, agenda, and context. This segment sets the foundation for collaboration by outlining the purpose of the exercise, the key themes, and the overall framework for the multi-risk assessment.

This plenary session explores the evolution from the African Medicines Regulatory Harmonization (AMRH) initiative to the establishment of the African Medicines Agency (AMA). Speakers will highlight key milestones, challenges, and opportunities in strengthening regulatory systems and ensuring sustainable access to quality, safe, and effective medical products across Africa.

Participants to gather for the official group photo, followed by a relaxing tea/coffee break. Afterward, please join the poster session to explore research presentations and interact with presenters.

This session will explore strategies to enhance coordinated regulatory oversight across countries and promote sustainable local pharmaceutical manufacturing. Presentations and discussions will focus on regional collaboration, capacity building, and policy frameworks to support harmonisation and innovation.

This session will discuss approaches to strengthen systems for detecting, preventing, and responding to substandard and falsified medical products. Participants will share experiences and best practices on regulatory collaboration, surveillance, enforcement, and public awareness initiatives aimed at protecting public health and ensuring the integrity of medical supply chains.

This session will feature abstract presentations highlighting regulatory experiences and innovations that address emergencies and pressing public health priorities. Discussions will focus on lessons learned from emergency responses, accelerated regulatory pathways, and strategies to enhance preparedness and resilience of health systems through effective regulation.

This session will explore the role of regulatory systems in strengthening clinical trial oversight and preparedness for future public health challenges. Presenters will share global experiences, best practices, and lessons learnt in ensuring ethical, efficient, and quality-assured clinical research, with a focus on building resilient and responsive regulatory frameworks across Africa.

This session will discuss the establishment, accreditation, and regulation of bioequivalence centres across Africa. Speakers will highlight the importance of bioequivalence studies in ensuring the quality, safety, and efficacy of generic medicines. The session will also address regulatory requirements, regional harmonisation efforts, and opportunities for collaboration to strengthen local testing capacity.

This session will present key lessons and experiences from the continental pilot initiative on the listing of human medicinal products. Speakers will discuss progress made, challenges encountered, and implications for future implementation of a harmonised listing framework across African regulatory agencies.

Kenya National Anthem African Union National Anthem

This session will explore regulatory approaches to address public health emergencies, changing disease patterns, and the growing burden of non-communicable diseases (NCDs). Presenters will share lessons learned, innovative strategies, and policy frameworks aimed at strengthening preparedness, response, and regulatory oversight for emerging health challenges.

This session will focus on leveraging innovation and artificial intelligence (AI) to enhance regulatory processes and manufacturing practices. Presenters will share case studies, technological solutions, and strategies for integrating AI to improve efficiency, decision-making, and compliance across the regulatory and pharmaceutical manufacturing ecosystem.

This session will focus on strategies to combat substandard and falsified medical products (SFMP) using advanced data systems, innovative technologies, and collaborative frameworks. Presenters will discuss case studies, digital surveillance tools, and multi-stakeholder approaches that enhance detection, prevention, and response efforts across regulatory authorities.

This session will feature abstract presentations highlighting strategies and innovations to build resilient regulatory systems for ensuring the quality of medicines in Africa. Speakers will discuss lessons learned, best practices, and policy frameworks that strengthen regulatory oversight, promote access to safe medicines, and enhance health system resilience.

This session will explore the concept of regulatory reliance as a strategic approach to strengthen regulatory systems in Africa. Presenters will discuss how leveraging trusted assessments from other regulatory authorities can enhance efficiency, reduce duplication, and promote timely access to quality medicines across the continent.

This session will explore strategies to strengthen organisational structures and develop human capacity within regulatory and pharmaceutical institutions. Presenters will share experiences, best practices, and frameworks aimed at enhancing workforce skills, institutional effectiveness, and sustainable professional development.

This session will introduce the creation of the College for Africa Regulatory Science Professionals (CARSP). Presentations will cover its objectives, governance structure, membership, and planned activities aimed at strengthening regulatory science expertise and professional development across the continent.

This plenary session will highlight innovative digital platforms and technological solutions that support regulatory processes and health system strengthening. Presenters will demonstrate tools, share implementation experiences, and discuss how digital innovations can enhance efficiency, transparency, and collaboration across regulatory authorities.

This session will summarise the key highlights, discussions, and outcomes from Day 2 of the SCoMRA meeting. It will provide an overview of progress made during the parallel and plenary sessions, setting the tone for the final day’s deliberations and next steps.

This plenary session will highlight the importance of partnerships in strengthening regulatory science and advancing regulatory affairs in Africa. Speakers will discuss collaborative models involving regional bodies, academia, industry, and development partners that foster innovation, capacity building, and harmonisation of regulatory practices across the continent.

This session will discuss strategies to enhance harmonized regulatory oversight across African countries while maximizing the impact of local manufacturing investments. Presenters will share experiences and initiatives that promote coordination, build regulatory capacity, and support sustainable growth of Africa’s pharmaceutical manufacturing sector.

This session will explore mechanisms for advancing pooled procurement and strengthening intra-African trade in health products. Speakers will discuss policy frameworks, collaborative models, and regional initiatives that promote market integration, improve access to quality-assured medicines, and enhance the sustainability of local manufacturing and supply chains across the continent.

This session will focus on strengthening regulatory systems and advancing harmonisation efforts to improve access to safe, effective, and quality-assured medical products across Africa. Presenters will discuss progress, challenges, and opportunities in implementing continental and regional frameworks that facilitate regulatory convergence and promote public health outcomes.

This plenary session will highlight best practices and lessons learned in adopting and implementing international standards to achieve regulatory convergence. Speakers will share experiences from regional and global initiatives that foster alignment of regulatory requirements, enhance cooperation among authorities, and strengthen trust and efficiency in medical product regulation across Africa.

This closing plenary will provide a comprehensive synthesis of key outcomes, lessons learned, and recommendations from SCoMRA VII. Discussions will focus on consolidating insights from parallel and plenary sessions, identifying actionable steps, and outlining future directions to strengthen regulatory science, harmonisation, and access to quality medical products across Africa. Speakers: • Lead Rapporteur Closing Remarks • WHO • AMA • AUDA-NEPAD • Kenya PPB