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Session 0102: DESIGN AND CONDUCT VALUE-ADDED AND HIGH QUALITY POST-MARKETING STUDIES
Session Chair(s)
Jane LIN, MD
VP, Strategic Medical Affairs
Johnson & Johnson Medical (China) Ltd., China
Post-marketing studies account for a large portion of studies in the product life cycle. The objectives and methodologies applied in the post-marketing phase are diversified. Different research methodologies have their specific features, strengths and limitations, and are subject to different rules and regulations. As of today, there are no clear official guidelines in China to define these studies. In this session, speakers from industry and academia will discuss the scientific, operational and regulatory aspects of various methodologies and how these principles can be applied in China to enhance value, quality and compliance of post-marketing studies to maximize benefits and reduce risk to the patients.
Speaker(s)
Considerations In Design and Successful Execution of Observational Research
Agnes Rivaille PINATEL, PhD
PRA, France
Scientific Affairs Director, Late Phase Services
Observational Research to Enhance Innovative Medicines' Impact on Patients and Society
Wei DONG
Roche, China
Senior Director, Deputy Site Head for Global Product Development in AP PDY
Using Outcomes Research for Product Life Cycle Management & Payer Support
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
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