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AI Trends in Pharma: Enhancing Drug Safety and Regulatory Compliance for 2025
Future-proofing compliance with technology: safety and regulatory strategies and trends
Jan 03, 2025

As therapeutics increase in complexity and global demand continues to rise, drug sponsors must adapt their pharmacovigilance (PV), Medical Information (MI), and lifecycle management (LCM) approaches to accommodate new challenges. Many drug sponsors are considering how technologies like artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) can improve existing PV, MI, and LCM workflows. To seamlessly integrate these technologies, sponsors are also assessing the impact of partnering with experienced technology providers. To prepare your teams for 2025, consider how AI and other innovations are helping drug sponsors manage growing workloads.

How will the relationship between pharma and AI evolve in 2025?

It is important to stay diligent and adaptive to technological trends to ensure continued market success and proper lifecycle management for your product. Throughout 2024, AI was implemented across LCM, MI, and PV workflows to accommodate changing volumes and needs. Now, experts are projecting the following AI trends in 2025:

  • A continued evolution and expansion of AI applications in PV, including more efficient PV case processing via automated data collection and initial adverse event reporting.
  • The usage of AI to create productivity enhancements and improved customer engagement in MI, including leveraging AI to aid with high inquiry volume.
  • Evolving guidance from regulators on the usage of AI in pharma, including an emphasis on taking a risk-based approach to implementation.

How can pharma companies improve their agility while staying compliant?

Drug companies must build a broad toolkit, emphasize cross-team collaboration, and enlist the help of seasoned experts wherever possible. Some recommendations include:

  • Working with local qualified persons for pharmacovigilance (QPPVs) that assist companies in meeting local regulatory requirements while maintaining global consistency and compliance.
  • Ensuring robust collaboration across key teams — safety and regulatory — to allow for integrated project management and oversight across functional areas.
  • Leveraging robust guardrails for AI solutions to ensure they produce compliant responses to customer inquiries.
  • Partnering with vendors that have ample experience leveraging AI solutions across PV, MI, and LCM.

Ready to learn about the compliance trends for 2025?

In a recent webinar hosted by IQVIA, experts across key functional areas spoke about the trends they are seeing across this space, including increased adoption of AI across MI and PV, evolving partnerships with streamlined service providers, and growing regulatory acknowledgement of AI. Looking to explore what trends are ahead in 2025? Watch the full webinar or read the white paper, 2025 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech.

 

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