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Discovery and Basic Research
Prologue

Prologue: How Artificial Intelligence will Redefine the Roles of Scientific and Medical Writers

On Demand
Location:Online Only

Discovery and Basic Research

Regulatory submissions, characterized by their structured data and highly templated format, are ideal candidates for drafting by generative artificial intelligence (gAI) and structured content authoring (SCA) software. By harnessing the combined power of gAI and SCA, and Retrieval Assisted Generation (RAG) the traditionally time-consuming and labor-intensive process of submission drafting can be dramatically expedited with concomitant improvements in quality and consistency of messaging. This webinar presentation will explore strategies for leveraging the combined power of gAI, RAG and SCA as a cost-effective tool to maximize the productivity of scarce, highly skilled and qualified regulatory writers. The aims of this presentation are as follows:
• Provide an overview of the nonclinical data requirements and format of Investigational New Drug (IND) submissions
• Define the qualifications, experience, capabilities and role of an effective regulatory writer
• Describe a typical, current paradigm for drafting IND submissions
• Provide an overview of the capabilities of gAI, RAG and SCA, and the way these platforms work together to assist regulatory writers
• Explore the nascent and evolving relationships of gAI and SCA to current and future regulatory environments

To view all Prologues, visit our library here and click "Enroll".

Learning Objectives:

  • Gain an in-depth understanding of nonclinical content required for a compliant regulatory submission and its suitability for drafting by AI tools
  • Clearly understand the necessary qualifications, experience and capabilities of effective regulatory writers and how artificial intelligence can maximize the productivity of these individuals
  • Understand the complementary characteristics of 3 AI tools suitable for drafting regulatory submissions and how they are transforming submission drafting and the role of the regulatory writer
  • Evaluate the broader impact of artificial intelligence on regulatory processes and how it influences decision-making, risk assessment, and compliance
  • Gain insight into FDA perspectives on the use of AI in the drug approval process