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Regulatory Guidance and Papers on Technology Innovations
Session Chair(s)
David Meats
Director, Regulatory Services Management
Certara, United States
This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.
Learning Objective : Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.
Speaker(s)
AI and Technology Trends and Regulation Introduction
David Meats
Certara, United States
Director, Regulatory Services Management
Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD
Sanofi, United States
Global Medical Writing and Document Management Head
Regulation Guidance
Louise Lind Skov, PhD
Novo Nordisk A/S, Denmark
Head of Content Digitalisation
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