6月9日泰国FDA Boontarika Boonyapiwat博士学术报告预告

    报告题目：Quality control for biopharmaceuticals
    报告人：Boontarika Boonyapiwat
    报告时间：6月9日下午3:00
    报告地点：新教1006
    报告人简介：
    Boontarika Boonyapiwat, Ph.D. (Thailand) is the Head of the Biological Testing Laboratory at the Bureau of Drug and Narcotic, Ministry of Public Health. Boontarika received her Master Degree and Ph.D. in Pharmaceutical Sciences from King’s College, University of London. Over the past 10 years, her work has focused on the quality control of biopharmaceuticals. She reviewed the quality documents for the registration of biopharmaceutical products and biosimilars for the Thai Food and Drug Administration (FDA) and was also a member of the expert committee for the Thai FDA to set up the Specific Guidance for Erythropoietin Biosimilar as a prototype of biosimilar guideline and also many other guidelines for biopharmaceutical products in Thailand. She has been invited as an expert by World Health Organization to join in the informal consultation meetings for drafting “Guidance on scientific principles for regulatory risk assessment of biotherapeutic products” and “WHO Guidelines on the Quality, Safety and Efficacy of Biotherapeutic Products Prepared by Recombinant DNA Technology”. Her current works include the analytical tests for biopharmaceuticals such as somatropin, erythropoietin and botulinum toxin.
    Today, her presentation will focus on the basic principle for the quality control of biopharmaceuticals.