Sharon N Kiggundu, born in Kampala, Uganda, is a dedicated and experienced professional specializing in clinical trial regulation. With over eight years of extensive experience, she has developed a strong expertise in assessing Clinical Trial Applications, focusing on the risk-benefit analysis to ensure the protection of clinical trial participants. Sharon has conducted numerous Good Clinical Practice (GCP) regulatory inspections at clinical trial sites. Her role has also involved developing and reviewing technical guidance documents for clinical researchers, sponsors, and the pharmaceutical industry, emphasizing patient rights, safety, and the promotion of clinical research within Uganda. Sharon holds a Master of Science in Clinical Epidemiology and Biostatistics at Makerere University. Prior to that, she graduated with a Bachelor of Pharmacy from Makerere University College of Health Sciences. Her commitment to continuous learning is evident from her participation in various short courses, including a Gene Therapy course and Immunology-Immuno-oncology course both at Harvard Medical School and several clinical trial regulation and ethics courses. In her professional journey, Sharon has held several significant roles. Since January 2018, she has been serving as a Regulatory Officer and Inspector of Drugs (from 2023 to-date) at the National Drug Authority (NDA). Previously, she was a Supply Chain Management Apprentice at Medical Access Uganda Limited in 2017, a Supervising Pharmacist and Technical Director at Tremol Pharmacy in 2016, and part of the Pharmacy dispensing staff at First Pharmacy Limited from 2014 to 2017. She also gained valuable experience as a Pharmacy Intern at Rubaga Hospital and a part-time staff member at Aga Khan University Hospital Nairobi. Sharon is highly detail-oriented, resourceful, and possesses exceptional analytical and communication skills. She is proficient in Microsoft Office, Adobe, SPSS, R software and STATA. Fluent in both oral and written English and Luganda, Sharon's dedication to her field and her ability to multi-task effectively have ensured her success in regulatory activities, consistently upholding the highest standards and exceeding expectations. Education: MSc in Epidemiology and Biostatistics, Makerere University (2025) Pharmacy Internship, Rubaga Hospital (2015 - 2016) Bachelor of Pharmacy (B.Pharm), Makerere University College of Health Sciences (2011 - 2015) Uganda Advanced Certificate of Education (U.A.C.E), Uganda Martyrs’ Secondary School Namugongo (2009 - 2010) Uganda Certificate of Education (U.C.E), King’s College Budo (2005 - 2008) Grants: • Project Team Member, The Consortium for Clinical Research Regulation and Ethics Capacity in Africa (CCRREEA Grant): January 2022 to March 2023. • Project Team Member, ACCESS AFRICA2 Grant: November 2024 to-date • Technical Project Coordinator-NDA UG, The Consortium for Developing Regulatory Capacity of Clinical Trials Using Gene Therapy Products and Strengthening Pharmacovigilance in the Conduct of Clinical Trials in East Africa (CAPACITY 2023 Grant): April 2024 to-date Short Courses: - Regulatory and Ethics Training program on Gene and Cell-based Therapies - UC-CNC & INFARMED, Portugal (June to July 2025) - Data Analysis and Visualization Using R (March 2025) Immunology - Immuno-oncology Course, Harvard Medical School (January - March 2025) - From Clinical Trials to Marketing Authorization - INFARMED Online Course (February 2025) - 2024 EU Good Clinical Practice Inspectors' Working Group Workshop, Larnaca Cyprus (October 2024) - Training on Genetics and Gene Therapy by the American Society of Gene and Cell Therapy (ASGCT) (October 2024 - March 2025) - AVAREF-EDCTP Training Workshop on Assessment of Clinical Trial Applications, Windhoek Namibia (July 2024) - African Vaccines Regulatory Forum (AVAREF) Clinical Trials Inspections Training Course (July 2024) - Gene Therapy Course, Harvard Medical School (April – June 2024) - AAI Clinical Trial Regulation and Ethics digital course, BIO Ventures for Global Health (BVGH) (February – May 2024) - Clinical Vaccine Development and Biomanufacturing, University of Oxford (October 2022) - PMDA-MRCT Webinar 2021, Tokyo, Japan (January 2021) Conferences and Meetings: • The Clinical Investigators' Summit (TCIS) Africa 2026; Speaker on Regulatory Harmonization across African Countries; May 2026. Professional Memberships: • Registered Pharmacist, Pharmacy Board, Uganda Ministry of Health • Member, Pharmaceutical Society of Uganda Languages: English (Fluent) Luganda (Fluent) Sharon's commitment to excellence and her extensive experience in the pharmaceutical and clinical trial regulation sectors make her a valuable asset to any organization aiming to advance healthcare outcomes.