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Regulatory and GCP Quality Trends in Emerging Markets

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
217

Room Number:
6E

Level:
Intermediate

Type:
Session

Title:
Regulatory and GCP Quality Trends in Emerging Markets

Chair(s):
Federico Feldstein, JD
Vice President, Head of Medical Regulatory Compliance
Pfizer Inc, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
IRBs and Sites Quality Cerifications in Latin America: Do We Really Have a Trend Regarding This Matter in the Region?
Charles Schmidt, MD
Head Scientific Medical Advisory Board, Prof., Santa Casa Medical
Estern Medical CRO, Brazil

CRO Perspective
Deborah Wade
Vice President, Process Quality Management
PAREXEL International, United States

Regulatory Perspective
Chih-Hwa Wallace Lin, PhD
Researcher and Acting Director, Biotechnology Unit
Board of Science and Technology, Executive Yuan, ROC, Taiwan