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Regulatory Guidance and Papers on Technology Innovations
Session Chair(s)
David Meats
Director, Regulatory Services & Medical Affairs 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)
David Meats
Director, Regulatory Services & Medical Affairs Management, Certara, United States
AI and Technology Trends and Regulation Introduction
Madhavi Gidh-Jain, PHD
Global Medical Writing and Document Management Head, United States
Regulation Guidance and Concensus Papers
Louise Lind Skov, PHD
CEO & Co-founder, Metamorphic AI, Denmark
Regulation Guidance
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