Helen Byomire Ndagije, PhD Pharmaco-Epidemiologist | Public Health Advocate | Regulatory Science Leader I am Dr. Helen Byomire Ndagije, a dedicated pharmaco-epidemiologist with over 20 years of progressive experience in regulatory science, pharmacovigilance, and public health systems strengthening. As a Fellow of the International Society of Pharmacovigilance (ISoP) and a holder of a Doctorate in Public Health, I have honed my expertise in medicines regulation, clinical trials oversight, and regulatory inspections across Africa. Professional Highlights: Leadership in Pharmacovigilance: Since 2006, I have led the Ugandan National Pharmacovigilance Centre, pioneering Africa's first decentralized pharmacovigilance system. My commitment to enhancing medicine safety has positioned Uganda at the forefront of global health initiatives. Public Health Emergency Preparedness: I have played an integral role in public health responses during pandemics, including COVID-19, where I contributed to expedited clinical trial approvals via joint scientific reviews in the African Vaccine Regulatory Forum (AVAREF). Regulatory Collaboration: As former Vice Chair of AVAREF, I transformed a network of 19 countries into a formal entity that now supports regulatory harmonization across African Union member states. This model has been recognized by WHO and has facilitated joint reviews and reliance mechanisms. Grant Leadership: I have secured and managed grants exceeding £2 million from prestigious organizations, including the Gates Foundation and the European & Developing Countries Clinical Trials Partnership (EDCTP), to advance regulatory frameworks and digital systems for clinical trials and pharmacovigilance. Innovative Regulatory Approaches: My work emphasizes the use of artificial intelligence and digital tools to enhance pharmacovigilance practices, notably through the AU Smart Safety Surveillance (3S) Project, where I advocate for data governance and transparency. Contributions to Global Health: I have actively engaged with WHO in various capacities, including the development of ethical guidelines for unregistered interventions during health emergencies and participation in the EMA’s Good Vigilance Practice Inspectors Working Group. My insights have informed critical assessments in pharmaceutical safety. Areas of Interest: Pharmacovigilance, post-market surveillance, and signal management Clinical trials oversight and Good Clinical Practice (GCP) Regulatory inspections and compliance with GMP and GVP Market intelligence and management of substandard and falsified medical products Innovation within regulatory systems, including emerging technologies and digital health Development of legal and policy frameworks to support regulatory strengthening Motivation to Collaborate: My dedication to improving public health outcomes and regulatory frameworks across Africa drives my eagerness to collaborate with organizations such as CARSP and other stakeholders. Together, we can advance the collective mission of ensuring access to safe, quality, and efficacious medical products. I am passionate about contributing to impactful initiatives through scientific assessments, expert consultations, and capacity-strengthening activities that uphold the highest standards of public health and safety.