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Managing Data at Arms' Length: China
Program Code:
108
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
CHAIR
:
Ralph Douglas Harkins,
SR, PhD (SCHNON), Senior Statistical Consultant and Project Manager,
RDH Statistical Consulting Service, United States
Nearly 15 years at FDA as Director of Biometrics Division 4. another 15 years in the pharmaceutical industry in various VP and Director positions in statistics and data management. Currrentyl working as a consulting statistician primarily in DSMB and expert witness areas.
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SPEAKER
(S):
Ivan Yu Zhai, MD,MBA (SPKNON), CEO, GCP CMIC ClinPlus Co., Ltd., China
Ethel Kagan,
RN (SPKNON), President,
Innovations Clinical Research, LLC, United States
Ethel Kagan is a nurse with more than more than 25 years experience in various capacities in the Clinical Research field. She has conducted international trials and has worked with many well known investigators and researchers. Her experience extends to industry, CROs and AROs.
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Barton L. Cobert,
MD,FACP (SPKNON), President,
BLCMD Associates, LLC, United States
Dr. Cobert is a gastroenterologist with over 25 years in the pharmaceutical industry with senior positions in drug safety and clinical research. He is now consulting in drug safety, quality and clinical research.
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Description
This forum will focus on CFDA-approved sites, data generation and reporting, electronic data capture, and the role of clinical research coordinators, clinical research associates, and other data management professionals in Chinese clinical trials.