Ketryx Guide to RAPS Convergence 2023
RAPS Convergence is a yearly gathering on global regulatory affairs that serves as a nexus, bringing together representatives from industry, regulatory agencies, research institutions, academia, and clinical entities. The conference's goal: to generate discussion and innovation in the regulatory landscape while synchronizing scientific advances, regulatory measures, and strategic business considerations.
Where and when is RAPS 2023?
RAPS Convergence 2023 will be held at the Palais des Congrès de Montréal in Montréal, Canada at 1001 Pl. Jean-Paul-Riopelle, Montreal, QC H2Z 1X7, CA.
The nearest airport is Montréal-Trudeau International Airport, approximately 20 minutes away.
The conference runs from Tuesday, October 3rd to Thursday, October 5th.
Link to local transportation to/from the conference site.
How can I find Ketryx at the event?
You can find the Ketryx team in the exhibit hall at Booth 533 during regular exhibition hours, 10am-2:30pm.
Link to the RAPS 2023 Floor Plan
Attend Erez Kaminski’s talk on chage management for cloud-based applications
Date & Time: Thursday, October 5, 2023
Location: Spark! Stage, Booth 323
Title: The Future of Change Management for Cloud-based AI/ML Medical Software
The rapid adoption of AI/ML in cloud-based medical software demands effective change management. This session explores the challenges posed by AI/ML in software and provides a framework to validate AI/ML-based applications, ensure FDA compliance, and prevent product development delays.
Learning Objectives:
1. Understanding AI/ML validation challenges: Understand the challenges and opportunities in AI/ML validation and refine your team’s SOPs.
2. Get the latest on FDA Requirements: Learn about FDA expectations and relevant guidances to AI/ML in medical software including the April 2023 draft guidance, Marketing Submission Recommendations for a Predetermine Change Control Plan for AI/ML-enabled device Software Functions.
3. Effective change management strategies for RA teams: Learn best practices tailored for Regulatory Affairs teams confronting the reality of incorporating AI/ML into medical device software. The focus will be on strategies that ensure FDA compliance and enable rapid, responsive, and reliable change management.
Interested in the topic but not attending? Sign-up for our email list to receive a synopsis and other relevant topics.
Book a meeting with the Ketryx team at RAPS
Email our team at events@ketryx.com to set up a time to meet, ask questions, or see a demo of Ketryx or stop by Booth 533 during regular exhibit hours (10am-2:30pm).
Whether you’re visiting Montreal for the conference or other business, you can also book a meeting directly here. We look forward to meeting you in-person at the event!
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