She has been involved in EMA activities since 2009, first in the Scientific Advice Working Party
(SAWP) and since 2012 as a member of the COMP.
Dr Narayanan was also a member of the Committee for Advanced Therapies of the European Medicines Agency (EMA/CAT) and represented EMA/CAT in the Scientific Advice Working Party
(CHMP/SAWP), giving him extensive experience in the regulatory aspects of ATMPs and other complex biologics.
CTI had also announced in June that they have agreed on pathways for regulatory approvals for XYOTAX in recent meetings with the United States Food and Drug Administration and the European Medicine Agency's Scientific Advice Working Party
. Lung cancer continues to be a major killer of men and women on both continents.
18 applications for PRIME were received as of 6 April 2016 and subsequently assessed by EMAs Scientific Advice Working Party
, Committee for Advanced therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP).
According to the company, the focus of the INOpulse clinical programme is the continued development of its nitric oxide therapy for patients with pulmonary hypertension (PH) in agreement with European Medicines Agency (EMA) through their Scientific Advice Working Party