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Program Code:
278
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Fred Feldstein, JD (SCHNON), Head of Primary and Consumer Healthcare BU Quality Assurance, Pfizer Inc, United States
SPEAKER
(S):
Hui-Ping Chang, MPharm (SPKAGY), Taiwan Food and Drug Administration (TFDA), Taiwan
Pediatrician with Master and Doctorate Degree in Pediatric Infectious Disease. Twenty years experience in clinical research in Latin America in academia, pharmaceutical, and CRO industries
|
Roan Martin, (SPKNON), Sr Director, PAREXEL International, United States
Description
This session will discuss how increased globalization of clinical development and continued advancement in the clinical trial environment, standard of care, and regulations has brought challenges to successfully execute studies with quality and cost-effectiveness in emerging markets. It is important to evaluate cultural attributes, local health care regulations, site/vendor capabilities, and identify the critical quality factors up-front to ensure a high quality trial that will withstand regulatory scrutiny.