GCPs in Emerging Countries

Track:
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)

Day & Time:
June 25, 4:00PM - 5:30PM

Session Number:
278

Room Number:
156AB

Level:
Intermediate

Type:
Session

Title:
GCPs in Emerging Countries

Chair(s):
Fred Feldstein, JD
Senior Director, Head of GCP/GLP/PV QA, Primary Care and Consumer BUs
Pfizer Inc, 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.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Simultaneous Global Clinical Trials and Coordinated Conformation to GCP Compliance in the Asia Pacific Region
Chih-Hwa Wallace Lin, PhD
Director, Division of Resource Development
Center for Drug Evaluation, Taiwan

Panelist
Roan Martin
Senior Director and Head of Research Regulatory Compliance (RRC)
PAREXEL International , United States

Panelist
Representative Invited
Clinical Reviewer, New Medicine Application and Regulation of Biological Product
Dirección General de Medicamentos Insumos y Drogas (DIGEMID) , Peru