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Session 8, Track 2: Automated Authoring: The Perfect Harmony of SCA and Gen AI
Session Chair(s)
Theresa Pinnell, MLS
Director of Regulatory Solutions
Kivo, Inc., United States
Preparing sections of regulatory dossier, such as Module 3 CMC documentation, typically takes more than 8 months for a new drug application, once all the data is available. With some foundational elements, creative solution design and enabling technologies, we can reduce that time to 8 weeks. In this session, presenters will share their journiesey in acceleratinge submissions, lessons learned, and what success could look like.
Automated Authoring: The Perfect Harmony of SCA and Gen AI - Vaibhav Shinde, Deloitte
The Future of Regulatory Filings: A Digital Transformation - Mike Abernathy, Amgen Inc.
Automated Authoring: The Perfect Harmony of SCA and Gen AI - Matthew Birmingham, Workiva
Learning Objective : - Demonstrate how authoring solutions can be used to author regulatory documents more efficiently
- Differentiate the benefits and uses of structured content authoring in parallel with supporting technologies (AI, Scripting, Gen AI)
- Share lessons learned with their own organizations to start or continue their own authoring automation journey
Speaker(s)
Automated Authoring: The Perfect Harmony of SCA and Gen AI
Vaibhav Shinde
Deloitte Consutling, United States
Consulting Managing Director
The Future of Regulatory Filings: A Digital Transformation
Michael Abernathy, MS, RAC
Amgen Inc., United States
Executive Director, Global Regulatory Affairs
Automated Authoring: The Perfect Harmony of SCA and Gen AI
Matthew Birmingham, MS
Workiva, United States
Manager of Solution Development
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