Pradip Paul, Strategic Pharmacovigilance and Risk Management Consultant, United States
Dr. Paul is engaged in the Pharmacovigilance for over 13 years, and 20 years of experience in Clinical research. He received his medical degree from Dhaka Medical Collage and his MS from NJIT, USA. Earlier he worked in Ciba-Geigy, Schering AG, and at Sanofi in Gobal Pharmacovigilance & Epidemiology.
Dr. Freddie Ann Hoffman is CEO of HeteroGeneity, LLC, a Washington, DC based consulting firm that focuses on the scientific, business and regulatory development of complex, heterogeneous products for the US market.
Dr. Dou is an expert reviewer for the Botanical Review Team in CDER. Prior to FDA, he had worked on medicinal plants for anticancer drugs. He received a Ph.D. degree in Pharmacognosy from the University of Mississippi. His B.S. and M.S. degrees were from Beijing University of Chinese Medicine.
Description
Natural Health Products (NHP) is a rapidly growing area in the pharmaceutical and allied industry. Use of NHP as dietary, nutritional supplement or herbal remedies is getting through revolutionary changes — particularly with new initiatives of obtaining regulatory approvals. This showcase will focus on the observed recent trends. Developed by the Natural Health Products (NHP) SIAC.
Learning Objectives: Define strategies for developing prescription medication from the natural health products' domain Assess how the scientific validity of natural health products can be made Describe regulatory aspects of Rx developments.