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Regulatory and GCP Quality Trends in Emerging Markets
Session Chair(s)
Federico Feldstein, JD
Vice President, Global Head of R&D Quality Compliance
Johnson & Johnson, United States
This session presents an understanding of the regulatory environment and challenges that may exist, the trends identified through GCP audits and inspections, and harnessing the opportunities of conducting trials in emerging countries.
Learning Objective : Discuss the regulatory environment in emerging markets; Recognize challenges and opportunities in the conduct of clinical trials in emerging markets; Identify GCP quality trends in emerging markets through audits and inspections.
Speaker(s)
IRBs and Sites Quality Cerifications in Latin America: Do We Really Have a Trend Regarding This Matter in the Region?
Charles Schmidt, DrMed, MD, MSc
Tigermed, Brazil
Head of Latin America
CRO Perspective
Deborah Wade
PAREXEL International, United States
Vice President, Process Quality Management
Regulatory Perspective
Chih-Hwa Wallace Lin, PhD
Board of Science and Technology, Executive Yuan, ROC, Taiwan
Researcher and Acting Director, Biotechnology Unit
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