09.00 Opening Remarks from IQPC and the Conference Chair

09.10 An Overview of Pharmacovigilance and Pharmacoepidemiology in China

• Introducing the pharmacovigilance system and the main challenges in China
• Using pharmacoepidemiology methodologies to improve signal detection
• Understanding possible challenges associated with signal detection
• Providing a perspectives from the healthcare stakeholder

Dr. Wang DaYou
Chief Pharmacist
Hua Shan Hospital (Teaching Hospital of Fudan University)

09.50 Examining Adverse Drug Reaction (ADR) Reporting System and Pharmacovigilance Regulatory Framework in China

• Understanding the imperatives of establishing a comprehensive and effective ADR monitoring system in China
• Specifying regulatory requirements for drug companies
• Identifying the main challenges for pharmacovigilance development in China
• Forecasting the direction of the future development

Dr. WenMin Du
Executive Director, Shanghai Centre for Adverse Drug Reaction Monitoring
SFDA

11.00 An update on Pharmacovigilance Regulatory Framework in Hong Kong

• Highlighting the importance of pharmacovigilance to drug safety
• Understanding the process to monitor the safety and ADR in Hong Kong
• Providing regulatory aspects of pharmacovigilance in Hong Kong

Representative
Department of Health
The Government of the Hong Kong Special Administrative Region of the People’s Republic of China

11.40 An Update from Uppsala Monitoring Centre: The Global WHO Pharmacovigilance Network

• Overview of the WHO International Drug Monitoring Programme
• Building a harmonised global pharmacovigilance network
• The advantages of a single global database system for safety information and analysis
• Highlighting the efforts to be made in Asia

Dr. Marie Lindquist
Director
Uppsala Monitoring Centre

12.20 Qualified Person Responsible for Pharmacovigilance in the European Economic Area (EU-QPPV)

• Overview of EU-Pharmacovigilance system requirements
• Responsibilities of the EU-QPPV
• Interaction of the QPPV with Competent Authorities (EMA, Local HAs)
• Collaboration of the QPPV with the central PHV Department and the local Affiliates
• Hands on examples the QPPV’s daily work

Dr. Ute Hoeffner
EU QPPV
Novartis Consumer Health GmbH

14.00 Cast Study: Best Practice of Safety Reporting for Clinical Trials and FDA Final Rule

• Complying with risk management requirements for clinical trials and post authorisation
• Safety reporting system for clinical trials
• An update on the FDA final rule on safety information during clinical trials
• Examining the impact on the pharmaceutical companies

Dr. Ming Ji
Senior Medical Director in Clinical Safety Evaluation Global Pharmacovigilance
Abbott

14.40 Cast Study: Developing and Implementing a Risk Management Plan to Get Fast-Track Approvals

• What are the essential elements in a risk management plan
• Understanding the regulatory development and enforcement of risk management plan in Europe
• How do pharmacovigilance scientists participate and contribute to the risk management plan
• Sharing best practices on implementing a sound risk management plan

Rebecca Wang, MD, FRCP, FACC
Head, Regional Center for Asia Pacific
Roche Product Development Safety Operation

15.50 Recent Development for Pharmacovigilance Regulations in East Asian Countries

• What is pharmacovigilance harmonisation and why it is important?
• What are the benefits for regulators and for the industry respectively?
• What are the efforts being made to achieve harmonisation?
• What needs to be done for taking this to the next step?

Jean-Christophe Delumeau
Head of Pharmacovigilance, Asia Pacific
Bayer Healthcare Global R&D Centre

16.30 Learning from the Pharmacovigilance System in South Korea

• An overview of the current pharmacovigilance system in Korea: Goals and systems
• Important regulations on drug safety information management and drug evaluation
• Engaging the key stakeholders
• Detailing the ADR reporting system in Korea
• Proposing possible ways to improve the PV system in Korea

Byung Joo Park, Md, MPH, PhD
Professor & Chairperson, Department of Preventive Medicine
Seoul National University College of Medicine

17.10 Case Study: Effective Pharmacovigilance Strategies for Mainland China, Taiwan and Hong Kong

• Comparing the regulatory environment and ADR systems for Mainland China, Taiwan and Hong Kong
• Uncovering unique challenges for setting up PV strategies in these markets
• Developing a cohesive and comprehensive strategy plan from the organizational level
• Case studies: what can be learned

Xue Tang
Senior Quality Standards & Drug Safety Manager
Pfizer Pharmaceuticals China

17.50 Chair’s Summary & Q&A. End of Day One Presentations