08:00 – 09:00
Registration
09:00 – 10:30
Opening Ceremony
Welcome Speech
Comfort Ogar, President, ISoP Africa Chapter
10:30 – 11:00
Coffee Break and Poster Viewing
11:00 – 13:00
Session 1: Strengthening PV Systems, Regulation & Governance
Chair: Thuli Makhene, Pharmacovigilance Country Head, South East and West Africa, Bayer
Co-Chair: Mamadou Madiou Diallo, President of the Guinean Organization for Pharmacovigilance
11:00 – 11:20
Keynote Address
Dr. Mimi Darko, Director General, African Medicines Agency
11:20 – 11:40
WHO Global Pharmacovigilance Strategy: From Vision to Practices
EunMi Kim, Technical Officer, World Health Organization
The WHO Global Pharmacovigilance Strategy moves from vision to practice by providing a smart, risk‑based, collaborative, and integrated framework that countries can tailor to their needs. It is designed to be practical and sustainable, ensuring that every country—especially LMICs—can build a PV system capable of protecting patients, detecting risks early, and responding effectively to evolving global health challenges.
11:40 – 12:00
Comparative Analysis of Pharmacovigilance Regulations Among East-African Countries
Betty Mwaniki, Pharmacist, Kitui County Referral Hospital, Kenya
Anastacia Naidoo, Pharmacovigilance Country Lead – South Africa and Sub-Saharan Africa, MSD, South Africa
Within the East African Community (EAC), a Harmonized Compendium for PV was developed to promote regulatory convergence. However, deviations from global standards and inconsistent national implementation of the regional framework continue to undermine effective PV governance.
12:00 – 12:30
Panel discussion: Pharmacovigilance en Afrique : État des lieux, défis et synergies entre Régulateurs et Industrie
Adji Marieme Ndiaye, Region Africa Patient Safety Manager, Novartis Cote d’Ivoire S.A.S.U
Dr. Kampadilemba Ouoba, Lecturer and Researcher, Joseph Ki-Zerbo University, Director of Pharmacovigilance, Pharmaceutical Authority, Burkina Faso
This panel will highlight progress, persistent challenges, and emerging opportunities for collaboration between regulatory authorities and the pharmaceutical industry in strengthening pharmacovigilance (PV) systems across Africa
12:30 – 12:40
Oral Abstract Presentation: Patient Safety First: Strengthening Continental Pharmacovigilance Collaboration through the African Medicines Agency
Fudeni Ndahangoudja, Ministry Of Health And Social Services, Namibia
Pharmacovigilance (PV) systems in Africa continue to face challenges including underreporting of adverse drug reactions (ADRs), limited regulatory capacity, and fragmented cross-border data sharing.
12:40 – 12:50
Oral Abstract Presentation: Signal Detection and Management in African Pharmacovigilance Systems: A Quantitative Assessment of Capacity, Barriers, and Enablers
Alemayehu Duga, Africa Centres for Disease Control and Prevention, Ethiopia
This study aimed to evaluate the capacity, barriers, and enablers of signal detection and management within national PV Centres across African Union (AU) member states.
12:50 – 13:00
Oral Abstract Presentation: Medication error reporting in South Africa: an analysis of reports submitted to the South African Health Products Regulatory Authority (2020–2024)
Hanlie Steyn, Medicine Usage in South Africa (MUSA), North-West University, South Africa
Shanelle Moopanar, North-West University, South Africa
Medication errors are a significant and preventable cause of patient harm. National regulatory authorities play a critical role in detecting, analysing and mitigating these errors through spontaneous reporting and post-marketing surveillance.
13:00 – 14:00
Lunch
14:00 – 15:40
Session 2: Digital Transformation & Data Science
Chair: Ronald Kiguba, Senior Lecturer, Makerere University, Uganda
Co-Chair: Rama Diop, CareSafe, Senegal
14:00 – 14:20
From Telemedicine to Safer Care: Building Patient-Centred Digital Healthcare Systems in Namibia and Beyond
Dr Armid Azadeh, CEO and Medical Director, OnCall
Sharing lessons from Namibia’s digital health journey and how innovative healthcare models can create safer, smarter and more responsive systems for African patients
14:20 – 14:40
Future of work in an AI PV era
Andrew Mitchell, CEO/Founder, YEZA.ai, United States / South Africa
Andrew Mitchell is a long‑standing PV technology innovator, provides a forward‑looking perspective on how AI is reshaping pharmacovigilance work, workforce roles, and regulatory expectations.
14:40 – 15:00
Artificial Intelligence and Machine Learning (AI/ML) in Pharmacovigilance.
Dr. Macarius Donneyong, Associate Professor, The Ohio State University
Dr. Macarius Donneyong’s presentation focuses on how AI and machine learning can transform pharmacovigilance (PV) by enhancing the detection, understanding, and prevention of adverse drug events (ADEs).
15:00 – 15:10
Oral Abstract Presentation: Adoption of Artificial Intelligence among Pharmacovigilance Professionals in Africa: Determinants, Opportunities, and Implementation Challenges
Kennedy Odokonyero, African Pharmaceutical Network, Kenya
While AI adoption is expanding in high-income countries, evidence on awareness, acceptance, and readiness among African PV professionals to use them remains limited.
15:10 – 15:20
Oral Abstract Presentation: SafeDocAI: An AI driven approach for local pharmacovigilance safety documents generation
Rene Ngaboyisonga, Novartis Ghana Limited, Ghana
SafeDocAI automates extraction, translation, and structuring of these documents to improve quality and accelerate submissions. Initially launched as a Patient Safety initiative for internal process efficiency and progressed through iterative testing ahead of validation and deployment.
15:20 – 15:35
Pharmacoviglance at the Finger Tip
Dr. Edinam Agbenu, Vaccine Safety and Quality Officer, WHO AFRO
A demo on web apps for effective Pharmacovigilance
15:35 – 16:00
Coffee break
16:00 – 17:40
Session 3: Pharmacovigilance Across the Product Lifecycle & Innovation in PV
Chair: Omar Aimer, President, International Society of Pharmacovigilance
Co-Chair: George Sabblah, Deputy CEO, Technical Operations Division, FDA-Ghana
16:00 – 16:20
Pharmacovigilance Across the Product life Cycle: Aligning Innovation, Regulation and Stakeholder Roles
Prof Albert Figueras, retired Prof University of Barcelona, independent consultant
16:20 – 16:40
Background Rates of Adverse Events for Vaccine Evaluation
Dr. Kimberley Gutu, Programme Manager, BRAVE project (Background Rates of Adverse Events for Vaccine Evaluation in Africa)
Dr. Gutu discusses the critical role of background rates of adverse events of special interest (AESIs) in evaluating vaccine safety. Her insights draw from her leadership in post‑COVID‑19 vaccine AESI surveillance and her broader experience in vaccine safety and effectiveness research
16:40 – 17:00
Evaluation of Vaccine Safety Data Challenges for Africa: Implications for Practice
Prof Hannelie Meyer, Head: South African Vaccination and Immunisation Centre, Sefako Makgatho Health Sciences University
Prof. Meyer draws on decades of regional and global vaccine‑safety experience to outline the critical challenges Africa faces in evaluating vaccine safety data and the practical implications for strengthening pharmacovigilance systems.
17:00 – 17:10
Oral Abstract Presentation: Evaluating Electronic Health Record Readiness for Vaccine Safety Surveillance in African Hospital Settings: Evidence from BRAVE
Jessica Ann Yun, Wits African Leadership in Vaccinology Expertise (Wits-Alive), University of the Witwatersrand, South Africa
Timely vaccine safety surveillance relies on high-quality clinical data to estimate background rates of adverse events of special interest (AESIs) and detect safety signals.
17:10 – 17:20
Oral Abstract Presentation: Knowledge, perception, and practices of reporting Adverse Events Following Immunization among Healthcare Workers in Bariadi district, Tanzania
Raphael Kambona, Simiyu Regional Referral Hospital, Bariadi, Tanzania
This study assessed knowledge, perception, and practices of reporting AEFI among HCWs in Bariadi district, Tanzania
17:20 – 17:30
Oral Abstract Presentation: Eco-pharmacovigilance in Africa: comparative analysis of household medicine disposal and a proposed digitally-mapped take-back pilot
Gathai Mundia, Zihi Institute, Kenya
Improper household pharmaceutical waste disposal represents a critical eco-pharmacovigilance blind spot across Africa.
17:30 – 17:40
Q & A
18:30 – 22:00
Gala Dinner