09.00 – 12.00 Workshop A: Learning the Current Development and Challenges for Pharmacovigilance and Drug Risk Management in China (Inclusive of 30 minutes break & lunch)

Workshop Leader:

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

13.00 – 16.00 Workshop B: Pharmacovigilance Auditing and Inspection (Inclusive of 30 minutes break)

Rationale:

To ensure absolute drug safety and patient safety, internal audits and external inspections are conducted regulatory which require lot of preparation work and need to be handled carefully. Different stakeholders will be involved as well which adds onto the complexity. It is critical for the team to be properly prepared and make sure every step is taken right to lead to a fruitful result.

What will be covered:

• Understanding different types of audits and inspections and their specific requirements
• What do to before, through and after an audit/inspections
• What are the main documents involved and how to prepare them effectively
• Gathering important information from the audit and follow up properly
• Developing good communications strategies throughout the inspection/audit
• Conducting a mock inspection

Your workshop leader:

TBC

09.00 – 16.00 Masterclass: Pharmacovigilance Strategies for Clinical Trials (Inclusive of networking breaks & lunch)

Rationale:

Developing a drug safety and pharmacovigilance program for clinical trials has become increasingly complex yet important with more stringent regulations and more emphasis on safety. On the other hand, with China quickly becoming one of the largest clinical trials market with over 4000 active trials, the importance of managing safety information for these trials is more than ever significant. In this master class, several expert speakers will bring the best practice for pharmacovigilance strategies for clinical trials. Strategies, processes and relevant regulations will be thoroughly combed through.

What will be covered:

• Examining and presenting different regulations involved
• Developing a pharmacovigilance strategy for clinical trials
• Managing safety information and reporting through clinical trials
• Developing a proper risk management plan
• Understanding and mitigating the risks through clinical trials
• Discussing on the current status and challenges in China

Your Masterclass Leader: