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GCPs in Emerging Countries
Session Chair(s)
Federico Feldstein, JD
Vice President, Global Head of R&D Quality Compliance
Johnson & Johnson, United States
Simultaneous Global Clinical Trials and Coordinated Conformation to GCP Compliance in the Asia Pacific Region
Learning Objective : Discuss innovative approaches from industry and CROs to design and oversee quality up-front for global clinical trials; Recognize GCP quality trends in US and emerging countries; Define the GCP requirements in the Asia Pacific region for simultaneous global clinical trials; Explain perspectives from regulatory agencies in the emerging markets.
Speaker(s)
Simultaneous Global Clinical Trials and Coordinated Conformation to GCP Compliance in the Asia Pacific Region
Hui-Ping Chang, MPharm
TFDA, Taiwan
Section Chief, Clinical Trial on Drugs, Div Drug and New Biotechnology Products
Challenges in GCP: Latin America
Charles Schmidt, DrMed, MD, MSc
Tigermed, Brazil
Head of Latin America
A Global CRO's Perspective on Emerging Markets
Roan Martin
PAREXEL International, United States
Sr Director
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