Medpace Medical Director, Jim Wei, MD, PhD to Present at the Outsourcing Clinical Trials Conference, January 27-28, 2010
CINCINNATI, OH--(Marketwire - January 25, 2010) -
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Clinical Research |
Medpace |
-- The current status of the Chinese regulatory environment for conducting
clinical trials
-- Clinical facilities accredited by China sFDA to conduct trials
-- Advantages and disadvantages of conducting trials in China
-- Recent outcomes regarding US FDA site inspections in China
-- Strategic practices to conduct successful trials: planning, training, and
partnership
Dr. Wei has expertise in early phase drug development to bring drug candidates from the research bench to first-in-human and proof-of-concept (POC) studies. He has served as an expert consultant to many global, mid-size and small pharmaceutical/biotech companies across US, Europe, and Asia. Prior to joining Medpace in late 2007, he was a senior reviewer in the Office of Clinical Pharmacology, CDER/FDA between 1998 and 2007. Dr. Wei is a trained cardiologist in China and a certified clinical pharmacologist in the US.
Dr. Wei is a frequently invited speaker at international conferences in China such as Impact China IV Conference in Beijing, International Workshop on Mass Spectrometry and New Drug Development in Hangzhou, and the 2nd Asia-Pacific Conference of the International Society for the Study of Xenobiotics in Shanghai. In June 2009, Dr. Wei helped organize a Workshop on Science-based Regulatory Decision-making in Beijing between the US FDAAA and China CDE/SFDA to train review staff for China SFDA. In May 2008, Dr. Wei successfully conducted his workshops in Singapore and Hong Kong for Drug Development Strategies and Regulatory Challenges. He has spoken at many workshops in Europe and the US, such as Drug Clinical Development in Copenhagen, Denmark in November 2008 and the IND Workshop in San Francisco in February 2009.
ABOUT MEDPACE
Medpace is a leading global full-service clinical research organization providing Phase I-IV core development services for drug, biologic, and device programs. With medical and regulatory expertise in multiple therapeutic specialties, Medpace has assembled the industry's most experienced and therapeutically focused teams to execute at every level of the company's operations, providing complete and seamless drug development services. In June 2009 Medpace was rated as the best CRO by U.S. Investigators in the 2009 CenterWatch Site Survey.
Medpace creates strategic partnerships with pharmaceutical and biotechnology companies to provide the most efficient and cost-effective path to drug development -- from program planning and execution to product approval.
With 900+ employees and clinical trial experience in over 40 countries, Medpace has the global reach and capability to conduct studies and navigate regulatory requirements worldwide. In addition to Phase II-IV development services, Medpace provides Phase I / IIA clinical services from Medpace Clinical Pharmacology, central laboratory and therapeutically specialized testing from Medpace Reference Laboratories, complete bioanalytical services in all stages of drug development from Medpace Bioanalytical Laboratories, and central image management and reading from Imagepace.
Visit the Medpace website at www.medpace.com