Dr. Rania Ibrahim Hassan

Position: General Manager of The General Administration of Clinical Trials, C.A. of Biological, Innovative Products & Clinical Studies - Egyptian Drug Authority (EDA)
Categories: RA Speakers 2023

She has 19 years’ Experience as Regulator Covering different roles in in various fields as Good Clinical Practice – Good Pharmacovigilance Practice – Regulatory Affairs – Pharmaceutical Production – Quality Assurance – Technical Methodology – GMP Inspection – Health Care Quality , key functions such as Quality Compliance, Documentation, Personnel, Biosafety, Performance Improvement, Validation, and, Strategic Planning, Quality System Management, Management of Quality Function, Project Planning and Initiation, Quality Control Techniques, Production Steps through GMP Trainings and reviewing Manufacturer`s Master files and production summary protocols and working as operation and facility Manager in a Pharmaceutical Company During its renovation phase. And also responsible for assessing and evaluating and monitoring Conduction of different phases of Clinical Trials and also as being QPPV.


Furthermore, she has gained significant experience working through EDA task force through the journey of achieving ML 3 in Vaccine scope according to World Health Organization GBT