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Tutorial I: Basic Pharmacoepidemiology Designs

Cohort Studies

Soko Setoguchi, Duke Clinical Research Institute / Duke University School of Medicine, USA

Epidemiology Methods — case control study

K. Arnold Chan, i3 Drug Safety / Harvard School of Public Health, USA

Bias

Soko Setoguchi, Duke Clinical Research Institute / Duke University School of Medicine, USA

Tutorial II: Critical reading of Pharmacoepidemiology Publications

Group A

Phenylpropranolamine and hemorrhagic stroke — a case control study

K. Arnold Chan, FISPE, i3 Drug Safety / Harvard School of Public Health, USA

Group B

Self-Controlled Case Series Designs for Pharmacoepidemiology

Stephen Evans, London School of Hygiene & Tropical Medicine, UK

Topics I

Learnings from a disease registry of human avian influenza

Nancy Dreyer, the Avian Influenza Experts Group (AVEX)

Education I: Confounding

Confounding in Epidemiologic Studies

Kenneth J. Rothman, RTI Health Solutions / Boston University, USA

Education II: Signal detection

Signal Detection

Stephen Evans, London School of Hygiene & Tropical Medicine, UK

Education III: Advanced methods

Healthy starters, sick stoppers, and the value of new user designs with active referents in pharmacoepidemiology

Robert J Glynn, Brigham & Women's Hospital, USA

Symposium I: Therapeutic Risk Management

An EU Perspective on Risk Management

Stella Blackburn, European Medicines Agency

FDA's Sentinel Initiative — A National Strategy for Monitoring Medical Product Safety

Abraham G Hartzema, University of Florida, USA

Therapeutic Risk Management — Regulatory Perspectives

Lih-Jiuan Hsu, Center for Drug Evaluation, Taiwan

Therapeutic Risk Management: Where are we now?

Stewart Geary, Eisai Co., Ltd., Japan

Symposium II: Databases in Asia

Shanghai Health Database (SDMES) and Its Applications on Postmarkting Drug Evaluation

Wenmin Du, Shanghai Center for Adverse Drug Reaction Monitoring, China

HIRA Database and its Use in Korea

Hyung-Ho Kim, Health Insurance Review Agency, Korea

Design of a nationwide record-linkage surveillance system to monitor the safety of 2009 pandemic A(H1N1) vaccine in Taiwan

Wan-Ting Huang, Epidemic Intelligence Center, Taiwan Centers for Disease Control

Healthcare Database in Japan — full of CPOE, but no unique ID

Michio Kimura, Hamamatsu University School of Medicine, Japan

Development of Risk Assessment Technique - for Pharmaceuticals Utilizing Medical Database -

Kazuhiko Mori, Pharmaceuticals and Medical Devices Agency, Japan

Symposium III: Regulation for Drug Safety in Asia

Regulation for Drug Safety in Asia: Current Status of Drug Safety System in Korea

Byung-Joo Park, Seoul National University College of Medicine, Korea

Drug Safety Regulation in Taiwan

Lih-Jiuan Hsu, Center for Drug Evaluation, Taiwan

Regulation for Drug Safety in Japan

Daisaku Sato, Ministry of Health, Labour and Welfare, Japan

Drug-Safety-Related Regulation Changes in Asian Countries

Songlin Xue, Takeda Pharmaceuticals International, Inc., USA