Hebatallah Ibrahim Abd El-Salam is a senior regulatory affairs expert with over 15 years of professional experience at the Egyptian Drug Authority (EDA). She currently serves as General Manager of the General Administration of Biological Products within the Central Administration of Biological and Innovative Products, where she leads national regulatory oversight for biological products.

She has extensive expertise in the regulation of vaccines, biotechnology products, and other biological products, with a strong background in regulatory evaluation decision-making, and policy development.

She plays an active role in international regulatory harmonization, serving as an independent technical expert and advisor with several global and regional initiatives. she contributes to the African Medicines Regulatory Harmonization (AMRH) program through regulatory capacity development activities. She was a member of the Regulatory Capacity Development Technical Committee and was serving as Chair of the Vaccine Subcommittee.

She is also a member of the International Council for Harmonisation (ICH) Expert Working Group, contributing to the development of the ICH Q5E guideline annex for advanced therapy medicinal products (ATMPs).

She holds a Bachelor’s Degree in Pharmaceutical Sciences from Cairo University, a Master of Business Administration (MBA) and is currently a Doctorate program candidate in Quality Management.