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Breakout Session 3B: Pharmacovigilance and Risk Management
Session Chair(s)
Kenneth Y Hartigan-Go, MD
Professor, Dept. of Pharmacology, College of Medicine, University of Philippines, Philippines
Florence Houn, MD, MPH, FACP
Consultant, Florence Houn MD MPH LLC, United States
It is well recognized that despite rigorous pre-market regulation process, post-market surveillance is essential to ensure that the benefit/risk balance of health products remains favourable throughout the product’s lifecycle. In the recent years, known or potential safety issues that require monitoring are identified prior to product registration and ways of communicating these issues to healthcare professionals and patients, as well as enhanced surveillance methods are developed. These risk mitigating strategies are presented in the form of a risk management plan, specific for each product. In this session, representatives from both regulatory agencies and the industry will share on elements of pharmacovigilance and the implementation of risk management plans.
Speaker(s)
Cheng Leng Chan, PHARMD
Group Director, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore
Pharmacovigilance in Singapore
Kosuke Haneda
, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Pharmacovigilance Updates in Japan and Risk Management Plans
Siew Huey Liew
Associate Manager, Drug Safety and Epidemiology, Novartis (Singapore) Pte., Ltd., Singapore
New EU Legislation: Impact on Risk Management and Post Market Surveillance in Asia
Hubert Leufkens, PHARMD, PHD
Emeritus Professor of Pharmaceutical Policy and Regulatory Science, Utrecht University, Netherlands
Current Challenges to Cope with Risk Management of Medicines
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