About NERI

Flora Sandra Siami, MPH, RAC
Director, Regulatory Affairs
ssiami@neriscience.com

Ms. Siami joined NERI in July 2002 and has over 15 years of experience in clinical research, including federal regulations, ICH guidelines and international regulations (CAN, EU, CEE, Latin and South America, Australia and India). She has extensive experience in IND and IDE submissions and strategic planning for drugs, devices, biologics and combination products in over 30 clinical trials. She is responsible for all aspects of submissions to the Food and Drug Administration (FDA) and continuing expansion of industry-sponsored clinical trials and registries. Ms. Siami has worked on a variety of clinical trials overseeing all aspects of project management and FDA submissions, including adverse-event reporting. Ms. Siami has organized training of Good Clinical Practices, Fundamentals of Clinical Trials and Clinical Monitoring. She has contributed to operational policies and procedure to comply with applicable federal regulations.

She has contributed heavily in the field of artificial organs and received the Willem J. Kolff Young Investigator Award from the American Society for Artificial Internal Organs (ASAIO). Her expertise was also recognized by the International Society for Artificial Organs (ISAO) with the Travel Award for her work with Orphan Devices and as an invited speaker to the Japanese Society of Artificial Organs (JSAO). Ms. Siami has served on the editorial boards of ASAIO Journal, Therapeutic Apheresis and Dialysis and Clinical Lymphoma. She has given over 30 presentations at major medical scientific meetings and has 20 publications in major medical journals in her field of research.

She received her BS from Vanderbilt University and MPH in Epidemiology/Biostatistics from George Washington University.