Dr. Samar Hamedo

Position: Biologicals Registration Administration Manager, Egyptian Drug Authority (EDA)
Categories: Pharma Reg Speakers 25

Dr. Samar Hamedo is a highly experienced regulator who has dedicated her career to ensure the quality, safety and efficacy of biological products. With over 14 years of experience in marketing authorization of biological products in Egyptian drug authority (EDA).

Currently working as Manager of the Biological Products Registration Administration at Egyptian Drug Authority, where she leads the evaluation and regulatory oversight of vaccines, blood products, cell and gene therapies, and other biological products and contributing to decisions on the approvability of regulatory submissions.

Dr. Samar Hamedo holds a Bachelor of Pharmaceutical Sciences from the Helwan University, Egypt. She began her career as a biological registration specialist and steadily progressed to senior leadership roles as unit manager, contributing to the development of Biological Products Regulations in EDA (drafting & final issuance of the biological products guidelines related to procedural management of registration process and post approval changes [PACs]), Updating all SOPs regarding file submission, review process for different regulatory pathways, handling the query responses for new file and renewal file and review the product leaflets and labels, Developing and issuance of Reliance pathway guideline in biological products registration and PACs.