Diana Nakitto Kesi
BPharm, MSc. Clinical trials, CRA
Manager Clinical Trials-National Drug Authority Uganda
DAY 2: Regulatory Forum Speaker
Diana is a regulatory scientist with over 12 years’ experience in Clinical and Regulatory Research, Good clinical practices (GCP), Good clinical laboratory practices, Good Pharmacy Practice, Project Management, and regulation of clinical trials and observational studies.
She leads the clinical trials team at the National Drug Authority Uganda and her roles involves providing overall oversight of the conduct of clinical trials in the country to ensure that all clinical trials meet regulatory requirements before, during and after a clinical trial.
This involves development of guidelines and procedures for the different clinical trial processes, assessment of clinical trial protocols for approval and continuous monitoring of approved clinical trials through the post approval processes, safety monitoring, capacity building, conduct of GCP inspections and sensitizations to improve compliance, and has participated in several collaborative engagements with other regulators under joint review platforms such as the African Vaccine regulatory Forum (AVAREF).
She has also pioneered and coordinated several regulatory researches within the institution aimed at informing regulatory decisions and improving institutional performance and has participated in the writing and implementation of grants for the institution.