2023-02-09-艾昆纬-如何确保地方药物警戒合规性和效率（英）_12页_4mb

报告摘要

Global pharmaceutical companies face significant challenges in ensuring pharmacovigilance (PV) compliance and efficiency at the local affiliate level, due to regulatory complexity, varying country-specific requirements, cost constraints, and operational hurdles.

Regulatory Complexity: Navigating diverse local regulations, language requirements, data privacy rules (e.g., GDPRs), and the need for local expertise.
Health Authority Expectations: Local authorities impose evolving standards and expectations that are difficult to anticipate and uniformly implement.
Cost Pressures and Inefficiency: Balancing cost reduction with the need for qualified local staff, reliance on suppliers, and resource limitations.
Inconsistent Practices: Inconsistencies in local versus global PV operations lead to non-compliance risks, delays in reporting, and challenges in achieving audit readiness.
Technology Adoption Barriers: Implementing global digital PV strategies at the local level remains challenging due to the lag in technology adoption and specialized resource needs.

Local Language Support: Essential for reporting, data processing, and patient-related communications.
Data Privacy: Ensuring compliance with local data protection laws and restricting data from crossing geopolitical boundaries.
Local Expertise: Requiring on-the-ground PV professionals who understand specific country regulations and legal frameworks.
Global Integration and Oversight: Maintaining alignment between local operations and global standards through effective cross-functional collaboration and monitoring.

Implement Local QPPV: Appoint qualified local PV representatives fluent in-country language and familiar with local requirements to foster better relations with health authorities.
Adopt Localized Workflow: Streamline processes for MI and AE intake to support near real-time reporting while maintaining compliance.
Utilize Advanced Technologies: Employ AI-enabled translation and redaction tools, automated report generation, and conversational agents to handle high volumes and improve scalability.
Integrate PV Operations Globally: Create seamless collaboration between local and global functions via standardized systems and a unified regulatory intelligence database (RID).
Opt for Strategic Outsourcing/Benchmarking: Use shared resources or experienced partners like IQVIA to achieve economies of scale and regional expertise.
Invest in Business Transformation: Implement continuous performance upgrades incorporating technology-driven solutions to handle increased demand and evolving regulations.

AI-powered translation/redaction: Improves efficiency and accuracy in data processing while addressing language barriers.
Local Adverse Event Management: Combines human-centric support with AI for scalable and multilingual AE handling.
Regulatory Intelligence Database (RID): Provides real-time insights into country-specific PV, safety reporting, and legal updates.
Customizable KPI Dashboards: Offers enhanced oversight through data-driven analysis to support quality, compliance, and performance.

A collaborative, innovative, and integrated approach is critical for overcoming local-level obstacles and achieving regulatory compliance.
Partnering with experienced organizations like IQVIA can provide the necessary infrastructure, resources, and expertise for tailored PV operations.
Future improvements must leverage technology and innovation to streamline workflows and prioritize both compliance and efficiency.

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