Exploring Regulatory, Inspection, and Cultural PV Trends in APAC

Explore evolving APAC PV trends: cultural diversity, CBDT rules, inspections, RMPs, outsourcing, and vendor audit best practices.

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

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

With the rise of complex therapies and personalised medicines, the demand for robust medical and safety data analysis has surged. This whitepaper explores how integrated PV/MI processes, using a Single Source of Truth (SSOT) framework, can meet this demand, while...

Whitepaper: Computerised System Validation & Pharmacovigilance

Gain insights into optimised CSV solutions, and their role in effective risk management. Key Highlights: In-depth CSV risk management strategies Ensuring data integrity and reliability in PV systems Case study on validating a cloud-based safety database At Biomapas,...

Breaking silos across Medical Information & Pharmacovigilance

Discover solutions for effective PV & MI data management, including handling Adverse Events, Product Quality Complaints, and MI inquiries. Our experts will walk you through real-life examples and hands-on solutions. Looking to improve your PV & MI data...

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Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

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Exploring Regulatory, Inspection, and Cultural PV Trends in APAC

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

Whitepaper: Computerised System Validation & Pharmacovigilance

Breaking silos across Medical Information & Pharmacovigilance

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Big Enough To Cover All Your Needs.Small Enough To Care.

Clinical Research

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Quality Assurance

Exploring Regulatory, Inspection, and Cultural PV Trends in APAC

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

Whitepaper: Computerised System Validation & Pharmacovigilance

Breaking silos across Medical Information & Pharmacovigilance

Big Enough To Cover All Your Needs. Small Enough To Care.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

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