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NeuAge Institute (NAI)

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Workshop Details

Dates

December 12, 2024

Time

3:00 pm - 4:00 pm

Cost

FREE

Location

Online

Transforming Regulatory Affairs with Artificial Intelligence (AI)

December 12, 2024

Workshop Overview

In the evolving landscape of regulatory affairs, artificial intelligence (AI) is proving to be a game-changer, offering unparalleled efficiencies and insights for the industry. This workshop, inspired by a recent presentation at RAPS Convergence 2024 by Nyquist AI’s CEO, Michelle Wu, explores the transformative impact of AI in regulatory affairs. Participants will discover how AI can automate repetitive tasks, enhance decision-making accuracy, and provide substantial returns on investment. Through three real-world use cases, attendees will learn how AI is already streamlining complex regulatory processes, enabling data-driven decisions, and fostering innovation in regulatory workflows. This session offers a unique opportunity to see AI’s potential to reshape the regulatory landscape and achieve operational excellence.

Who Should Attend

This workshop is ideal for regulatory affairs professionals, quality assurance specialists, medical device specialists, compliance officers, data analysts, and pharmaceutical industry leaders interested in leveraging AI to enhance their regulatory processes. It is particularly beneficial for those looking to automate workflows, improve decision-making accuracy, and explore innovative tools that drive efficiency and compliance in the regulatory domain.

Workshop Outline

This workshop covers the following topics:

  • Introduction to AI in Regulatory Affairs
  • Automating Repetitive Regulatory Tasks
  • Enhancing Accuracy and Compliance
  • Use Case 1: Streamlining Document Review and Submission
  • Use Case 2: Data Analysis for Faster Decision-Making
  • Use Case 3: Risk Assessment and Mitigation with AI
  • Evaluating ROI from AI in Regulatory Affairs
  • Future of AI in Regulatory Affairs

Learning Outcomes

Understanding AI Applications in Regulatory Affairs

Gain a comprehensive understanding of AI’s current and potential applications in regulatory affairs.

Improving Efficiency Through Automation

Learn how AI can automate key regulatory tasks to save time and improve operational efficiency.

Enhancing Data-Driven Decision Making

Develop skills in utilizing AI for data analysis, enabling faster and more accurate regulatory decisions.

Assessing ROI and Innovation Potential

Understand how to evaluate the return on investment of AI implementations and recognize the future innovation possibilities AI offers for the regulatory industry.

Meet the Speaker

Michelle Wu

Nyquist AI

Michelle Wu

Michelle Wu is the founder and CEO of NyquistAI, with over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been featured by Forbes and has spoken at various conferences on AI in life science.

Before founding NyquistAI, she was the youngest global strategy manager at Novartis, where she played a pivotal role in the industry’s first and only asset swap deal between Novartis, Eli Lilly, and GSK. This experience highlighted the challenges of manual data research, sparking her vision to create NyquistAI. Before Novartis, she worked for BCG, advising major pharma and Medtech companies on their global product development and emerging market strategies. She holds an MBA from Stanford University.

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