09.00 Opening Remarks the Conference Chair

09.10 Building Pharmacovigilance Harmonisation in China: A Perspective from RDPAC

• Understanding pharmacovigilance efforts in China
• Bridging the regulators and the industry
• Key factors to contribute for pharmacovigilance harmonisation
• Calling for actions from the regulators and the industry

Conny Mo
Head of PV Work Stream
R&D-based Pharmaceutical Association Committee (RDPAC)

09.50 Case Study: Best Practice on Signal Collection, Monitoring and Analysis

• How to streamline the collection process from patients and hospitals
• Tracking and recording signals while ensuring their accuracy
• Sharing data mining techniques
• Evaluating the signals and their implications

Michal Borawski
International Pharmacovigilance Officer, Asia-Pacific Region
Sanofi-Pasteur

11.00 Strengthen the Pharmacovigilance Reporting System from the Basics

• Comprehensive PV reporting procedure
• Internal training and system support
• Case study 1: Handling AE originate from patient or patient’s relative
• Case study 2: Handling pregnancy case
• Case study 3: Handling SAE in registration clinical trial

Deng WuDe
Manager, Medical Section
Medical Affair Department Daiichi Sankyo Pharmaceutical Shanghai

11.40 Case Study: Post-Marketing Pharmacovigilance Best Practice

• Developing an effective post-marketing surveillance system
• What are the challenges for pos-marketing pharmacovigilance
• Applying datamining methods on post-marketing drug safety operations
• Case study: The Early Phase Post-Marketing Vigilance(EPPV) program in Japan

Michiko Yamamoto
Office of Safety
Pharmaceuticals and Medical Devices Agency, Japan

13.20 Case Study: Preparing for an Audit: Practical Steps to Get it Right

• What are the important steps when preparing for an audit: Discussing the process
• Developing a mock inspection to be prepared
• Thinking from the inspector’s perspective
• Sharing the common pitfalls

Guo XiaoJun
Patient Safety Manager
AstraZeneca China

14.00 Meeting Stakeholders’ Expectations through Managing Safety Case Related Legal Suits and Compensation Claims

• Insights from China - Understanding Chinese regulatory requirements and social insurance systems
• An update on the current practices of processing legal suits and compensation claims in China
• Suggesting possible improvement to meet consumer/patient expectations

Joy Li, MD PhD
Head of Medical Governance & Pharmacovigilance
GSK R&D China

15.10 Case Study: Developing Effective Drug Risk Management Strategies throughout Product Life Cycle

• The importance and implications for pre and post market risk management
• Developing risk management strategies for pre and post market stages
• Understanding and overcoming challenges in each steps
• Case study and lessons learned from Xi’an Janssen

Xiaobin Li
Senior Drug Safety Manager, Medical Affair Department
Xi’an Janssen Pharmaceutical Ltd

15.50 Panel Discussion: What Needs to be Done After Authorisation?

• What are the risks associated to drug safety after drug authorisation?
• What are the main challenges of reducing these risks?
• Examining different roles of regulators, pharmaceutical companies and health facilities
• Lessons learned from US and Europe

Panellists Include:

16.30 Pharmacovigilance Management System in the Global Trial – From a Global CRO Expertise

• Understanding the regulatory requirements in the global context
• Examining the role of CRO in the pharmacovigilance
• The importance of implementing a systematic pharmacovigilance management in global trial
• Mapping out the Pharmacovigilance Outsourcing Strategy
• Case Study: Offshoring strategy for Pharmacovigilance in ICON

James Fan MD MBS
Medical Director, Medical Affairs and Safety Services /Asia Pacific
ICON Clinical Research Pte Ltd

17.10 Chair’s Summary and Q&A. End of Conference