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Type: 04: MedAffairs-SciComm clear filter
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Wednesday, June 18
 

10:30am EDT

Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Following up on 1-year of use with AI and structured content authoring tools. The implementation of these tools, their successes, pitfalls, and metrics. This session is planned to be a follow up to the 2024 presentation.

Learning Objectives

A comprehensive understanding of the successes achieved through one year of using AI and structured content authoring tools in regulatory medical writing processes; Explain pitfalls encountered along the way as well as the presenting relevant metrics for evaluation and future directions for improvement.

Chair

David Meats, II

Speaker

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc


Speakers
DM

David Meats

Director, Regulatory Services Management, Certara
EA

Eishita Agarwal

Digital Innovation Manager, Medical Writing, GSK, India
Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into... Read More →
avatar for Louise Lind Skov

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

1:45pm EDT

Evolving Regulatory Considerations for Medical Affairs Communications
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Speakers
avatar for Torrey Cope

Torrey Cope

Partner, Sidley Austin LLP
Torrey Cope advises clients on a wide range of FDA regulatory issues. He is an experienced regulatory lawyer who regularly works on legal matters involving good clinical practice (GCP) and other requirements for clinical trials, marketing authorization, promotion, good manufacturing... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Forum
 
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Virtual
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
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