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Shanghai International Convention Center

May 11, 2014 8:00 AM - May 14, 2014 5:30 PM

No. 2727, Riverside Avenue, Pudong, 200120 Shanghai, China

6th DIA China Annual Meeting

Session 0102: DESIGN AND CONDUCT VALUE-ADDED AND HIGH QUALITY POST-MARKETING STUDIES

Session Chair(s)

Jane  LIN, MD

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)

Agnes  Rivaille PINATEL, PhD

Considerations In Design and Successful Execution of Observational Research

Agnes Rivaille PINATEL, PhD

PRA, France

Scientific Affairs Director, Late Phase Services

Wei  DONG

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

Nancy A Dreyer, PhD, MPH, FISPE

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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