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At the Impact China IV Conference in Beijing, China on 4-6 May, Dr. Weiwill speak on "The Role of Foreign Data and FDA Requirements." In hispresentation he will discuss how both pre-clinical and clinical data fromforeign countries has increased in Investigational New Drug Application (IND),New Drug Application (NDA), and Biologic License Application (BLA) submissionsin the US.
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Dr. Wei will talk about "Current FDA Policy and Opportunities for theChinese Pharmaceutical Industry" at the International Workshop on MassSpectrometry and New Drug Development in Hangzhou, China on 8-10 May. In hispresentation Dr. Wei will discuss regulatory policies that would help Chinesegeneric suppliers and the opportunities for botanical drug products in the USmarket.
At the Second Asian Pacific Regional Meeting of the International Societyfor The Study of Xenobiotics, held in Shanghai, China on 11-13 May, Dr. Weiwill speak on the "Current US FDA Recommendations on Drug Interaction Studiesand Challenges to the Pharmaceutical Industry." In this presentation he willreveal the challenges to the pharmaceutical industry -- the requirement of theknowledge level of drug metabolism and drug interactions, optimal design of invitro and in vivo studies, and integrated analyses to assess the risk/benefitratio of new drugs for potential harmful drug interactions.
Dr. Wei joined Medpace in November 2007 with extensive experience in theclinical trial regulatory aspects of early phase studies. He came to Medpacefrom the FDA where he served as a Senior Reviewer in the Office of ClinicalPharmacology and was also heavily involved in reviewing INDs and NDAs for theDivision of Metabolism and Endocrinology Products.
ABOUT MEDPACE
Medpace is a leading global full-service contract research organizationled by top therapeutic and regulatory experts who are driven to further theadvancement of pharmaceutical agents for use in cardiology, metabolism, andoncology. Medpace has assembled the industry's most experienced andtherapeutically focused team to execute at every level of the company'soperations, providing complete and seamless drug development services.
Through specialized regulatory expertise and therapeutically focusedclinical operations, Medpace creates strategic partnerships withpharmaceutical and biotechnology companies to provide the most efficient andcost-effective path to drug development -- from program planning and executionto product approval.
With more than 700 employees and clinical trial experience in over 40countries, Medpace has the global reach and capability to conduct studies andnavigate regulatory requirements worldwide within the core therapeutic areasof cardiology, metabolism, and oncology.
Medpace provides centralized image management and reading from Imagepace,centralized laboratory and therapeutically specialized testing from MedpaceReference Laboratories, and Phase I / IIa research services from MedpaceClinical Pharmacology.Visit the Medpace website at www.medpace.com Contact: John Wynne, 513-579-9911, x2407 [email protected]
SOURCE Medpace, Inc.
