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Looking Ahead: Safety & Regulatory Compliance Trends in 2024
An in-depth discussion on the impact of AI and regulatory changes on the pharmaceutical industry
Archana Hegde, Senior Director of Integrated PV Solutions
Michelle Gyzen, Senior Director of Regulatory Affairs and Drug Development Solutions
Alisa Hummings, Senior Director and Head of Medical Information and Local AE Intake Services
Michele Denarié, Principal of Regulatory Affairs and Drug Development Solutions
Simon Johns, Director of Medical Information and Marketed Product Safety
Jan 19, 2024

The pharmacovigilance (PV), safety, and regulatory landscape continues to evolve for patients, regulators, drug developers, and their partners. As technologies like artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and large language models (LLMs) become more accessible and integrated within workflows, safety and technology vendors must identify ways to integrate these offerings while ensuring ease of transition and affordability for pharma companies. As you explore ways to meet global regulatory standards, consider how emerging innovations can help you meet increasing adverse event and medical information volumes while improving digital accessibility for patients.

What’s on the 2024 Regulatory Affairs and Lifecycle Safety Horizon?

Historically, pharma companies have worked with multiple vendors to meet their safety, Medical Information, and regulatory needs. Typically using a handful of technology providers and a compliance services partner. In many instances, this system delays implementation due to services staff needing to train to use third-party technologies, and often forces pharma companies to serve as go-betweens. Working with a single vendor that provides both technology and compliance services can improve efficiency and increase synergy while yielding cost savings. Due to these benefits, many companies are shifting toward this combined model. In addition, experts predict the following trends in 2024:

  • Greater adoption of Generative AI (GenAI) tools trained by subject matter experts (SMEs), including literature reviews, case narratives, report summaries, and predictive analytics
  • AI and ML as tools to determine indication prioritization for drug platforms
  • Optical character recognition for inbound form digitization and auto redaction
  • Neural machine translation to conduct auto translation across languages and dialects
  • Rule-based automation for duplicate searches, case compare, or to merge and auto triage cases
  • NLP to extract and process literature for case-related information
  • End-to-end automation of electronic common technical documents (ECTDs)
  • AI “chatbot” agents to help field high-volume call centers and support human agents

How Will This Impact Customer Engagement?

With the integration of more AI systems, many pharma companies are navigating concerns about AI bots replacing humans in the industry. However, the success of intelligent automation technology will require the guidance and input of SMEs to ensure accuracy and regulatory compliance. As demands for the safety services field increase, AI is meant to serve as a tool to assist safety and regulatory experts by lightening their workload and freeing up bandwidth to focus on critical tasks.

Where Can I Learn More?

In a recent panel discussion on safety and regulatory predictions for 2024 and beyond, IQVIA experts, Archana Hegde, Senior Director of Integrated PV Solutions; Michelle Gyzen, Senior Director of Regulatory Affairs and Drug Development Solutions; Alisa Hummings, Senior Director and Head of Medical Information and Local AE Intake Services; Michele Denarié, Principal of Regulatory Affairs and Drug Development Solutions; and Simon Johns, Director of Medical Information and Marketed Product Safety, illuminate what changed in 2023 and how AI and machine learning are impacting each of their areas of expertise. Download the white paper, 2024 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech.

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