Speaker Profile

BIOGRAPHY

Amany Elshahawy is a regulatory scientist and inspector with deep expertise in biologicals regulation, quality systems, and clinical assessment; she holds a PhD in Pharmacology & Toxicology and an MBA. She combines laboratory, regulatory and inspection experience across national and regional bodies.
At the Egyptian Drug Authority (BIO‑INN) she serves as a dossier assessor and GxP inspector, evaluating CTD modules (M3–M5) for recombinant biologics, vaccines, plasma derivatives and extract products, preparing assessment and inspection reports, guiding manufacturers and CROs, and participating in CAPA follow‑up activities.
Amany previously led quality assessment and GLP inspection activities at NORCB, contributed to GMP inspections, and performed analytical and potency testing (ELISA, CE‑SDS, HPLC/FPLC, bioassays) while establishing SOPs and mentoring junior staff.
Amany has lectured in pharmacology and clinical pharmacy, authored peer‑reviewed research on neuroprotection, Chemobrain, immunology and biosimilars, and completed multiple advanced regulatory and GMP trainings (WHO, EMA, African GMP). She is proficient in regulatory dossier evaluation, risk assessment, and method validation and is committed to evidence‑based decision-making that strengthens product quality, patient safety, and local biologics access.