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Description
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, 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 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 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
Learning Objectives:
- Gain an in-depth understanding of nonclinical content required for a compliant regulatory submission
- Clearly understand the necessary qualifications, experience and capabilities of effective regulatory writers and how artificial intelligence can maximize the productivity of these individuals
- Gain an appreciation for the potential legal and ethical considerations associated with use of artificial intelligence for drafting regulatory submissions, including privacy, data protection, and bias
- Evaluate the broader impact of artificial intelligence on regulatory processes and how it influences decision-making, risk assessment, and compliance