Dr. Dalia Abou Hussein, Asst. Prof of Pharmaceutics and QA General Manager at the Egyptian Drug Authority (EDA), holds both a Master’s and a PhD in Pharmaceutics from Cairo University and brings over 23 years of regulatory expertise. She began her career at NODCAR as a quality control analyst and went on to serve on several key committees, including those for the evaluation of stability studies, CTD quality modules, clinical trials, and pricing.

At EDA, she has overseen the establishment of an integrated quality management system and successfully led the authority to achieve multiple certifications and accreditations, including ISO 9001:2015, ISO/IEC 17025:2017, ISO/IEC 17043:2010, ISO 17034:2026, as well as WHO GBT ML3 for both medicines and vaccines.

Dr. Abou Hussein is also an active member of WHO’s WLA-TAG, the AMRH Steering Committee, and the AMQF QMS Subcommittee. Since 2022, she has contributed as a Technical Advisor and Consultant to WHO’s Regulatory System Strengthening (RSS) program. She has additionally authored 18 peer-reviewed publications.

At the summit, she will present EDA’s journey toward achieving WHO GBT ML3 maturity level for both medicines and vaccines.