This Community aims to support and leverage the use of AI in change management best practices in digital transformation.
Why Use AI in Pharmacovigilance Activities ?
The Safety and PV AI Community of Experts aims to act as a forum to address the challenge of effectively integrating artificial intelligence (AI) into pharmacovigilance (PV) practices for the ultimate benefits of patients worldwide. The business problem at hand is the lack of a unified platform for industry professionals to share insights, best practices, and challenges related to the emerging field of AI in PV, as well as to develop a harmonized understanding of regulatory expectations and requirements. This gap hinders the advancement and implementation of AI technologies, which are crucial for improving the efficiency and accuracy of safety and PV processes. By fostering collaboration, knowledge sharing, and networking among industry peers, the forum seeks to accelerate the adoption of AI in PV while ensuring consistent interpretation and application of regulatory guidelines across different organizations and regions.
Solving this problem is important because the integration of AI in PV can significantly improve the detection, assessment, and prevention of adverse drug reactions. This leads to better patient safety, more efficient regulatory compliance, and overall improved public health outcomes. Additionally, a collaborative platform can drive innovation, reduce duplication of efforts, and ensure that best practices are widely adopted, benefiting the entire industry. The forum’s role in harmonizing regulatory understanding is particularly crucial as it helps companies navigate complex regulatory requirements consistently, reducing compliance risks and accelerating the implementation of AI solutions in PV processes. Furthermore, by identifying common use cases and collectively building robust business cases for AI initiatives, the forum enables organizations to better justify and secure investments in AI technologies, leading to more efficient resource allocation and faster adoption of innovative solutions across the industry.
Community Goals
The Safety and PV AI CoE will serve as a comprehensive platform fostering cross-organizational collaboration to enable the identification of cross-organizational trends, shared challenges, and opportunities in AI implementation while ensuring patient needs remain at the center of all initiatives.
Expected benefits :
- Quality Improvements:
- Adopting best practices and innovative AI solutions leading to more accurate and efficient PV processes.
- More consistent approach to AI validation across the industry
- Enhanced cross-functional alignment leading to more comprehensive safety monitoring
- Better integration of patient feedback into safety monitoring processes
- Improved signal detection through shared learning and best practices
- Cost Savings:
- Reduced duplication of efforts in AI implementation across organizations, reducing costly mistakes from shared learnings
- Shared investment in common use cases and solution development
- More efficient resource allocation through better business case development
- Lower compliance risks through harmonized approaches
- Time Savings:
- Faster implementation of AI solutions through shared learnings
- Reduced time in PV processes through consistent approaches
- More efficient cross-functional decision-making
- Accelerated identification and validation of safety signals