CINCINNATI, May 5 /Xinhua-PRNewswire/ -- Medpace, a leading global full-service contract research organization, announced that Jim Wei, MD, PhD, Medpace Director of Clinical Pharmacology, will address three international conferences in China in May. He will speak at the Impact China IV Conference in Beijing, at the International Workshop on Mass Spectrometry and New Drug Development in Hangzhou, and at the International Society for the Study of Xenobiotics in Shanghai.
At the Impact China IV Conference in Beijing, China on 4-6 May, Dr. Wei will speak on "The Role of Foreign Data and FDA Requirements." In his presentation he will discuss how both pre-clinical and clinical data from foreign countries has increased in Investigational New Drug Application (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions in the US.
Dr. Wei will talk about "Current FDA Policy and Opportunities for the Chinese Pharmaceutical Industry" at the International Workshop on Mass Spectrometry and New Drug Development in Hangzhou, China on 8-10 May. In his presentation Dr. Wei will discuss regulatory policies that would help Chinese generic suppliers and the opportunities for botanical drug products in the US market.
At the Second Asian Pacific Regional Meeting of the International Society for The Study of Xenobiotics, held in Shanghai, China on 11-13 May, Dr. Wei will speak on the "Current US FDA Recommendations on Drug Interaction Studies and Challenges to the Pharmaceutical Industry." In this presentation he will reveal the challenges to the pharmaceutical industry -- the requirement of the knowledge level of drug metabolism and drug interactions, optimal design of in vitro and in vivo studies, and integrated analyses to assess the risk/benefit ratio of new drugs for potential harmful drug interactions.
Dr. Wei joined Medpace in November 2007 with extensive experience in the clinical trial regulatory aspects of early phase studies. He came to Medpace from the FDA where he served as a Senior Reviewer in the Office of Clinical Pharmacology and was also heavily involved in reviewing INDs and NDAs for the Division of Metabolism and Endocrinology Products.
ABOUT MEDPACE
Medpace is a leading global full-service contract research organization led by top therapeutic and regulatory experts who are driven to further the advancement of pharmaceutical agents for use in cardiology, metabolism, and oncology. Medpace has assembled the industry's most experienced and therapeutically focused team to execute at every level of the company's operations, providing complete and seamless drug development services.
Through specialized regulatory expertise and therapeutically focused clinical operations, 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 more than 700 employees and clinical trial experience in over 40 countries, Medpace has the global reach and capability to conduct studies and navigate regulatory requirements worldwide within the core therapeutic areas of cardiology, metabolism, and oncology.
Medpace provides centralized image management and reading from Imagepace, centralized laboratory and therapeutically specialized testing from Medpace Reference Laboratories, and Phase I / IIa research services from Medpace Clinical Pharmacology.
Visit the Medpace website at http://www.medpace.com