We are pleased to announce our Keynote speakers.
by Alan Hopkins, BeiGene
Mr. Hopkins is the Vice President of Global Biometrics at BioGene, a pharmaceutical company founded in China. His speech is about building a wholly new international biometrics organization with best-in-class tools available to support the clinical data and analysis world-wide.
by Dr. Qin Huang, CFDA
Dr. Qin Huang, Doctor of Medicine, former senior clinical reviewer and chief review reporter of the National Center for Drug Evaluation (CDE), former deputy director of the statistics division (presiding work) and reviewer of vaccine clinical trial in CDE. He is currently a deputy chairman of several professional societies and professor at the university. Dr. Huang engaged in drug clinical review and statistical review for 16 years, focusing on the indications of cancer, digestion, psychology, vaccines and antibiotics. He presided over the formulation of several important regulatory documents of the CNDA. Before he worked in CDE, he worked in the clinical research in the AIDS Center of the Ministry of Health and the Second Affiliated Hospital of Harbin Medical University.
by Dr. Yuki Ando 安藤 友紀, PMDA
Dr. Yuki Ando, PhD, is a Senior Scientist for Biostatistics at Office of Advanced Evaluation with Electronic Data of Pharmaceuticals and Medical Devices Agency (PMDA). Currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Additionally, she works for Office of Advanced Evaluation with Electronic Data, the former Advanced Review with Electronic Data Promotion Group, and is responsible for promoting CDISC implementation and the use of submitted and accumulated electronic data in PMDA.
Pharmaceuticals and Medical Devices Agency (PMDA) started to accept electronic clinical study data with NDA on October 1st, 2016, and the new drug reviewers started to use submitted data for their review. Since the transitional period will be ended on March 31st, 2020, PMDA is now preparing for the next phase. In this presentation, current situation of electronic data submission in Japan and the concept of future use of accumulated data will be presented.