Biomapas Insights: Exploring Regulatory, Inspection, and Cultural PV Trends in APAC

In our latest discussion, Albert Bekfi, Head of Global Pharmacovigilance Operations at Biomapas, is joined by Theo Giannou and Wee Chuan Lau from Bloom Agents, a regional pharmacovigilance service provider with over 30 years’ experience across Asia-Pacific (APAC).

They share timely insights on the evolving PV landscape in APAC, including:

• Navigating cultural diversity across the region
• Digital transformation and tightened safety reporting
• China’s 2024 CBDT rules and implications for cross-border ICSR transfers
• Inspection trends across Japan, Australia, China, Southeast Asia and Malaysia
• Local risk-management strategies and country-specific RMP adaptations
• Best practices for PV outsourcing, distributor delegation and vendor audits