Artificial Intelligence is rapidly transforming the way regulatory professionals access information, generate content, analyze data, and support decision-making. Yet successful adoption requires more than simply knowing which AI tools exist. It requires AI literacy: an understanding of how these technologies work, where they can add value, their limitations, and how to use them responsibly within regulated environments.
AI Literacy Lab: A Hands-On Workshop for Regulatory Professionals is an interactive, full-day workshop designed to help regulatory professionals build practical AI skills that can be immediately applied to their daily work. Through demonstrations, guided exercises, group discussions, and real-world regulatory case studies, participants will explore how AI can support activities across the product lifecycle, from pre-submission planning through regulatory submissions, agency interactions, and post-market change control activities.
Learning Objective
By the end of this workshop, participants will be able to:
- Understand fundamental AI concepts, terminology, and capabilities relevant to regulatory practice.
- Evaluate the strengths and limitations of commonly used AI tools.
- Develop effective prompting techniques to improve AI-generated outputs.
- Identify opportunities to leverage AI across their daily regulatory workflows.
- Recognize key risks associated with AI use, including accuracy, bias, confidentiality, and overreliance.
- Understand the importance of human-in-the-loop principles.
- Use AI more confidently and effectively to support regulatory activities.
Who Should Attend:
- Regulatory professionals in medical devices, pharmaceuticals, biologics
- Quality, clinical, engineering, and compliance leaders seeking practical AI knowledge
- Professionals responsible for authoring or reviewing regulatory documentation
- RA specialists looking to build their technical toolkit and stay current
- Anyone curious about how AI will impact the future of regulatory strategy and execution
- No prior AI experience is required.
Location
Alcon Johns Creek – Commons Building (look for ‘Contact Café’ sign)
11460 Johns Creek Pkwy
Johns Creek, GA 30097
Directions and Parking:
Alcon Johns Creek encompasses several buildings and parking lots. To ensure you arrive at the correct location, please use the street address: 11460 Johns Creek Pkwy, Duluth, GA 30097.
Building and check in information:
The event will be hosted in the Johns Creek Commons building. Look for the exterior sign marked "Contact Cafe" to identify the correct building. A visual map is provided as an attachment for your convenience, detailing the building's location within the campus. Please locate the RAPS table adjacent to the building's entrance to check in upon your arrival.
Map of Alcon Campus
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Sponsor
