The integration of artificial intelligence (AI) in clinical trials offers transformative opportunities, from enhancing patient recruitment to optimizing data analysis. However, the use of AI also introduces a complex regulatory and cybersecurity landscape that professionals must navigate to ensure compliance and safeguard patient data.
This webcast provides an in-depth exploration of the evolving regulatory frameworks governing AI in clinical research, including guidance from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global agencies. Attendees will gain insights into how these regulations impact AI development, deployment, and validation processes. Additionally, the session will cover essential cybersecurity measures and best practices needed to protect AI systems and maintain data integrity throughout the clinical trial lifecycle.
Drawing from real-world examples and the latest industry trends, this webinar is designed to equip regulatory professionals with the knowledge needed to manage AI technology effectively while adhering to the highest standards of security and compliance.
This educational webinar will be followed by a demo of AgileWriter™, an AI-enabled authoring platform for clinical documentation that prioritizes accessibility and getting documentation to the correct audience, be it plain language or technical content.
Registration Fees & Deadlines
Learning Objectives
- Examine international AI regulations in clinical trials for guiding companies towards best practices based on ethical standards.
- Develop strategies for ensuring compliance with regulations and standards governing AI throughout the trial lifecycle.
- Review cybersecurity challenges and best practices for AI implementation.
- Evaluate case studies highlighting successful and compliant AI applications in clinical research.
Who Should Attend?
Clinical trial and IT professionals working in industry or academia, including those with a focus on regulatory, clinical operations, and medical writing.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Jeanette Towles
President and CEO, Synterex, Inc.
Jason Casavant
Executive Director, Medical Writing and Quality Assurance, Synterex, Inc.
Pallabi De
Senior Director, Medical Writing Technology and Content Architecture, Synterex, Inc.
Alex Olinger
Information Technology Manager, Synterex, Inc.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org