Medpace Director Of Clinical Pharmacology, Jim Wei, Md, Phd, Embarks On A Regulatory Policy Speaking

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6th May 2008, 02:54am - Views: 390









Medpace Director of Clinical Pharmacology, Jim Wei, MD, PhD, Embarks on a Regulatory Policy

Speaking Tour in China in May


CINCINNATI, May 6 /PRNewswire-AsiaNet/ --


    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 

Science Research Medpace, Inc. 2 image

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. 


 

    Contact:  John Wynne, 513-579-9911, x2407  

              j.wynne@medpace.com 

 

SOURCE  Medpace, Inc. 

    

    CONTACT:  John Wynne of Medpace, Inc., 

              +1-513-579-9911, x2407, 

              j.wynne@medpace.com

   

   Web site:  http://www.medpace.com


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