Saeedeh Fakhrzadeh

Senior Expert and head of Vaccine regulatory affairs dep.in Iran Ministry of Health

Biography

  • I hold a Diploma in Natural Science and earned my Pharm.D. degree in 1996 from Tehran Medical Science University in Iran. Later, in 2005, I completed my Master of Public Health from the same university’s Health Faculty.
  • Professionally, I have built a strong foundation in regulatory affairs and public health. My career began in 1998 at the Iran FDA's Pharmaceutical Affairs Department, where I contributed to establishing the first dedicated unit for biological products, built on a quality management system that, by 2010, received the WHO's functionality award. Initially, I served as an expert in dossier review, GMP inspection, and lot release of biologics, before progressing to Senior Expert and Head of Vaccine Regulatory Affairs. In these roles, I led GMP inspections for biological product manufacturing sites, both locally and internationally, supervised vaccine dossier reviews, and managed vaccine lot release. I also played an active role in national committees, contributing to the planning and management of vaccine availability for the Expanded Program on Immunization (EPI).
  • From 2019 to 2023, I served as the Head of the biologic department at the Iran FDA, where I oversaw regulatory affairs for a wide range of biological products, including vaccines, plasma derivatives, biotherapeutics, and cell and gene products, both domestically produced and imported biologics.
  • I was a longstanding member of the Iran National Committee for Immunization (NITAG) from 2008 to 2023 and participated in the National Committee for Adverse Events Following Immunization (AEFI) for causality assessments during this time. In addition, I led the Vaccine technical committee within the health technology office of the Ministry of Health and Medical Education and contributed to several national initiatives, including the National Authority for Polio Containment and the National OPV Switch Committee.
  • During the COVID-19 pandemic, I played a critical role in preparing guidelines and plans for Emergency Use Authorization (EUA) of vaccines as head of the biologic department and an active member of national COVID-19 vaccine committees.
  • Throughout my career, I have pursued extensive training in regulatory science, focusing on the quality and safety requirements for vaccines and biologics. This includes completing numerous national and international courses covering topics such as GMP, risk management, risk-based Inspection, quality systems, lot release, Good review practice, AEFI causality assessment, production, quality control, non-clinical and clinical evaluation of vaccines and other biologics, and so on.
  • My contributions have extended to key publications, including co-authoring the “Quality Assurance” book in 2003. I led the lot release component of a WHO vaccine quality project, receiving an award from the Iranian Minister of Health for my work between 2003 and 2006. I have also contributed to developing WHO guidelines, such as the Independent Lot Release guidelines, GMP for Biological Products and Changes to approved vaccine (variations), change management, and safe production and quality control of polio vaccine, reflecting my deep commitment to global health standards. Since 2011, I have represented Iran at WHO’s DCVRN and participated in the WHO Expert Committee on Biological Standardization (ECBS). I also served on the ACVAC panel for four years as a regulatory body representative from 2019.
  • Additionally, I have served as a temporary advisor to WHO for the assessment of national regulatory authorities for vaccines and have attended numerous WHO meetings, In 2023, I proudly became a member of the World Health Organization's ECBS.
  • My expertise in regulatory affairs, particularly in training manufacturers and regulators in Iran, has been vital, especially in developing and implementing COVID-19 emergency vaccine guidelines in 2020.
  • I retired from Iran FDA in 2023 to continue privately as a biological consultant. Throughout my career, I have been dedicated to ensuring the safety and quality of vaccines and biologics, and have tried to improve health outcomes.