Hadir Rostom

 

Dr. Hadir Rostom is a Pharmacovigilance consultant, and Lecturer at MSA University, Egypt, EMRO.

She has 24 years’ experience in Pharmaceutical sector, including 14 years extensively in pharmacovigilance domain. She is Co-founder and former head of the Egyptian Pharmacovigilance Center. She issued the first Egyptian Pharmacovigilance guidelines, and principally contributed in issuing the “Good Pharmacovigilance Practice guidelines in Arab Countries” (GVP-Arab), at that time, she introduced new regulatory concepts to boost PV practice at affiliate level for international pharmaceutical companies (e.g. National PV sub-system file & national display of a RMP). She initiated “Pharmacovigilance inspection- Risk based model”, and established the Egyptian Pharmacovigilance Inspection program, Furthermore, she acted for integrating pharmacovigilance teaching in Academia.

Her most notable pharmacovigilance contributions on the international level include; being a WHO consultant in Regulatory System Strengthening, she supported Regulatory Authorities in different countries to establish/enhance their pharmacovigilance system according to the WHO Global Benchmarking Tool. Acting as independent pharmacovigilance consultant and lead auditor for Pharma companies in different countries to evaluate their PV system compliance according to the applicable regulations.

Moreover, she is actively involved with International Society of Pharmacovigilance (ISoP) by leading Egypt Chapter and her Membership in ISoP Scientific Board and different working groups