Future-Ready Pharmacovigilance: Integrating AI With FDA's EDSTP Guidelines


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As the pharmacovigilance (PV) landscape evolves, integrating cutting-edge technologies like artificial intelligence (AI) is no longer optional – staying compliant, efficient, and prepared for the future is essential.

The FDA's Emerging Drug Safety Technology Program (EDSTP) signals a shift toward technology-driven regulatory expectations, creating challenges and opportunities for the PV community.

Join IQVIA’s esteemed panel of experts for an in-depth discussion on how AI can meet and exceed these new expectations. This webinar delves into the intersection of regulatory frameworks and technological innovation, offering insights into the future of PV and how organizations can navigate this transformative field.

Key takeaways include:

  • Regulatory insights: Understand the Center for Drug Evaluation and Research (CDER) guidelines and how EDSTP guidelines impact emerging technologies used in PV.
  • AI in action: Discover how AI can enhance PV processes, improving efficiency, accuracy, and compliance.
  • Technology integration: Explore the role of AI and other technologies in augmenting PV services, resulting in better safety case management and data processing.
  • Real-world applications: Gain insights from successful case studies where AI has driven measurable improvements in PV outcomes, such as real-time safety case management and natural language processing.
  • Future Proofing: Learn from real-world examples of how AI has been successfully integrated into PV systems to position your organization as a leader in PV innovation.
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Meet the Speakers

Patrick Brady, PharmD

Global Head, Therapeutic Innovation & Regulatory Science, IQVIA

Archana Hegde

Senior Director, PV Systems & Innovations, Lifecycle Safety, IQVIA

Updesh Dosanjh, MSc

Practice Leader, Technology Solutions, IQVIA

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