Speaker Profile

BIOGRAPHY

Loice Kikwai is a pharmaceutical scientist and regulatory affairs expert with over 18 years of global experience in medicines regulation, evaluation, and standardization across the USA, Middle East, Asia, and Africa. She has served in senior regulatory roles at the U.S. Food and Drug Administration (FDA), where she led bioequivalence assessments and policy development for generic drug submissions under the Office of Generic Drugs. Her extensive technical background includes the review and evaluation of clinical, bioequivalence, pharmacokinetic, formulation, and CMC data supporting product registration and market authorization. At the U.S. Pharmacopoeia, Dr Kikwai contributed to developing compendial standards and analytical methods that safeguard drug quality. Currently, she leads the Regulatory Affairs practice at Market Access Africa, and also serves as managing partner at LCK Pharmaceutical Consulting supporting national regulatory authorities (NRAs) and regional harmonization initiatives in line with WHO, ICH, and PIC/S standards. She has successfully led regulatory capacity-building and harmonization projects with SAHPRA (South Africa), Ghana FDA, Eritrea MOH, Saudi FDA, Oman MOH and others, strengthening systems in line with WHO GBT. A sought-after expert in medicines registration and good regulatory practices, Dr Kikwai has advised on dossier assessment, GMP inspection readiness, and reliance frameworks for NRAs across Africa, the Middle East, and ASEAN regions. She holds a Ph.D. in Pharmaceutical Sciences from Florida A&M University and a B.A. in Biology and Chemistry from Lincoln University, USA. Her work continues to advance regulatory convergence and access to safe, effective, and quality-assured medicines globally.