Speaker Profile

BIOGRAPHY

Hiram Maina Wachira is a PMP®-certified digital transformation ICT expert with over 15 years of extensive experience in driving the digitalization of public health and enterprise-level regulatory systems across Africa. He currently serves as the Chief Executive Officer and Lead Technical Consultant at Nextrans Solutions Limited, a Kenyan firm specializing in enterprise and regulatory digital systems that enhance governance, strengthen regulatory oversight, and enable data-driven regulatory collaboration. Over the past decade of progressive experience in digital governance and regulatory informatics, Hiram has directed the rollout of unified medicines and food regulatory solutions in Tanzania, Zambia, Uganda, Rwanda, and Ghana. His work being instrumental in helping several National Medicines Regulatory Authorities (NMRAs) advance toward WHO Global Benchmarking Tool (GBT) Maturity Level 3, resulting in measurable gains in review efficiency, transparency, pharmacovigilance, and data-driven decision-making. At the continental and regional levels, he has served as a technical advisor on the implementation of digital regulatory solutions for the AUDA-NEPAD on expert management and the COMESA Single Window Platform. Within the EAC framework, he serves as the Lead Software Developer under the Digital Health & Innovation Taskforce (DIDATI), where he champions an architecture-first, harmonization-driven approach that aligns national, regional, and continental frameworks — including the African Medicines Regulatory Harmonization (AMRH) programme and the emerging African Medicines Agency (AMA) — into a cohesive and sustainable digital regulatory ecosystem for Africa. His ongoing collaborations with the Zambia Medicines Regulatory Authority (ZAMRA), Burundi National Medicines and Food Authority (ABREMA), UNICEF, and other regional partners reflect a clear and actionable mission: to build a seamlessly connected African regulatory environment that accelerates local pharmaceutical production, facilitates intra-African trade, and safeguards the continent’s public health security through digital innovation. Hiram continues to serve as a thought leader and practitioner at the intersection of technology, regulation, and public health, contributing to Africa’s journey toward harmonized, data-driven, and sustainable regulatory systems.