Speakers
Yi REN, PhD, MBA
General Manager, Nanjing Medichem Bio-Pharmaceutical Development Co. , China
Dr. Ren is General Manager of Nanjing Medichem Biopharmaceutical Development Co. and General Manager and member of the board of directors of Chizhou Ruick Pharmaceutical Co. Previously, he was senior director and head of CMC at Roche R&D China and part of the core leadership team for Roche API, Formulation, Small Molecule R&D, Virology R&D, and China R&D. He has extensive experience in R&D, manufacturing, commercialization of generic drugs, and innovative pharmaceuticals, and is a co-inventor of Zelboraf, a novel treatment of malignant melanoma. Dr. Ren holds a PhD. degree in Organic Chemistry from the University of Toronto; postdoc training at the University of Michigan, and an MBA from Rutgers University in the United States.
Melly Lin
CMC Regulatory Policy Lead, Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Switzerland
Melly Lin is working at F. Hoffmann-La Roche Ltd. as CMC Regulatory Policy Lead. She is responsible for identifying policy priorities and supporting regulatory policy advocacy efforts for South East Europe, Central Asia and Egypt. She has over 20 years of experience in Regulatory Affairs, within that 13 years in CMC Regulatory Policy. She joined Roche China in 2004. There she held different positions with increasing experience and responsibility in regulatory filing. She took the responsibility as China Policy Lead from 2011 to 2019. She is now taking an active role in the middle east region by leading the EFPIA MERN LCM team. She is also chairing an industry network for South East Europe.
Christa Wirthumer-Hoche, PhD
Chair, EMA Management Board, Head, Austrian Medicines & Medical Devices Agency (AGES), Austria
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices Agency. Christa is the elected Chair of the EMA Management Board.
Fritz Erni, DrSc
Consultant, ICH expert, Switzerland
Dr. Fritz Erni has a Ph.D. from the Swiss Federal Institute of Technology (Dr. sc.nat. ETH) in Zurich and more than 35 years experience in research, development and quality assurance in the pharmaceutical industry.
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