Dalia Gaber El Khateeb
Dr. Dalia Gaber El Khateeb brings more than three decades of regulatory and laboratory leadership to pharmaceutical quality. She currently serves as Administration Manager of the hazardous products analysis laboratories at the Egyptian Drug Authority, having progressed from Quality Control Specialist for antibiotics and antivirals at NODCAR to Technical Manager and Deputy of the Antibiotics Lab, and Rapporteur on the chemical and physical committee. Beyond the regulator's side of the table, she has led technical departments in industry — building the data analysis and scientific justification behind biowaiver submissions, and equipping QC laboratories from the ground up. Her technical strength lies in HPLC operation and troubleshooting, method verification and validation, and hazardous waste and anticancer lab safety. Dr. Dalia holds a PhD in Industrial Pharmacy and Pharmaceutics from Cairo University, is certified in ISO/IEC 17025:2017 and ISO 45001:2018, and lectures and examines at several Egyptian faculties of pharmacy.
Experience
30+ Years
Regulatory laboratory leader specialising in quality control of antibiotics, antivirals and hazardous/anticancer products, with hands-on HPLC method development, verification and validation, plus R&D experience in biowaiver and IVIVC justification.
Industry Background
Pharmaceutical Quality Control and Regulatory Laboratory Management
Progressed from Quality Control Specialist for antibiotics and antivirals at NODCAR to Technical Manager and Lab Deputy of the Antibiotics Lab, then Administration Manager of the hazardous products analysis labs at the Egyptian Drug Authority. Also served as Rapporteur on the chemical/physical committee, Head of Technical Department at Egyptian R&D Company (biowaiver/IVIVC dossiers), and equipped QC labs for EMIC United (now Hikma Specialized).
Academic Background
PhD in Industrial Pharmacy & Pharmaceutics and Master in Pharmacy and Pharmaceutical Technologies
PhD from Faculty of Pharmacy, Cairo University (biopharmaceutical study on antidepressant drugs, 2013) and a Master's in Pharmaceutical Technologies (2001). Published in the International Journal of Pharmaceutics and Journal of Advanced Pharmacy, certified in ISO/IEC 17025:2017, ISO 45001:2018 and Lean Six Sigma Yellow Belt, and a lecturer/oral examiner at Mansoura, Helwan, Al-Azhar and MUST faculties of pharmacy.
Areas of Contribution
Hazard Handling and Safety MeasuresQuality AssuranceQuality ControlRegulatory AffairsResearch and DevelopmentAnalytical Method DevelopmentBioequivalenceTotal Quality Management