Dr. Doaa Rady

Position: Lot Release administration manager - Egyptian Drug Authority (EDA)
Categories: RA Speakers 2023

Dr. Doaa Rady is a highly experienced regulator who has dedicated her career to ensuring the quality, safety, and efficacy of biological products. With over 10 years of experience in the biological product sector, she has developed a deep understanding of the regulatory landscape and is widely recognized as an expert in her field.

 

She began her career as a lot release specialist at National Organization for Research and Control of Biologics, where she was responsible for release process for several biological products including vaccines and plasma derived medicinal products. During her tenure, she gained extensive experience in different regulatory functions.

 

Over the course of her time at the Egyptian regulatory authority, Doaa held several leadership positions, including serving as a team leader for the team establishing the risk-based lot release policy in Egypt, team leader for lot release team achieving WHO ML3 for LR function during benchmark of EDA, Egypt, and deputy of lot release department manager. In these roles, she was responsible for overseeing the review of a wide range of biological products, as well as she has active participation in many working groups responsible for providing guidance to industry on regulatory requirements and best practices.

 

She has also been an active participant in several professional organizations, including the International society of Pharmacoeconomic & outcome research (ISPOR) and the African Medicine Quality Forum technical committee which is One of the key components of The African Medicines Regulatory Harmonization (AMRH) initiative.

 

She has served on various international committees and working groups at ISPOR including Health equity special interest group, clinical outcome special interest group, real world evidence interest group and biosimilars interest group.

 

She had the opportunity to provide her feedback and insights to different regulatory guidelines and papers including ICH- Q9 quality risk management guideline, ICH-Q14 analytical procedure development, WHO approach towards the development of a global regulatory framework for cell and gene therapy products, ISPOR report on mapping HTA agency approaches for biosimilars value assessment and Primer on health equity research in health economics and outcomes research an ISPOR report. Moreover, Doaa Rady serves as peer reviewer for value in health journal and has active participation in reviewing research manuscripts and abstracts.

 

Doaa Rady holds a Bachelor of pharmaceutical science from the Helwan University, Egypt, a Master of Science degree in Microbiology & Immunology from Cairo, Egypt and Pharmacoeconomic and Health Technology Assessment Diploma from Cairo university in cooperation with Bournemouth university in UK She is a recognized leader in the field of biological product regulatory authority and is highly respected by her colleagues and managers.