8:00 am Morning Coffee & Check-in
8:55 am Chair’s Opening Remarks
Workshop A
9:00 am Get Ahead of the Curve: Learn How to Scale AI/ML to Accelerate MIDD Outcomes
Synopsis
With the rapid evolution of AI/ML, there is a pivotal opportunity to improve efficiency, speed and insight generation within MIDD. However, many MIDD professionals are unsure how to integrate these tools meaningfully. This interactive workshop will explore how to align AI/ML innovations with common challenges in modeling, from trial design and early planning to regulatory strategy.
This workshop is designed for hands-on learning and open dialogue, equipping you with the tools and confidence to integrate AI/ML into your MIDD strategy.
Join this workshop to:
- Explore the emerging potential of AI/ML in enhancing model performance and decision-making, and discuss real world applications of tools to streamline MIDD workflows, improving efficiency and consistency
- Understand how these tools can save time, enabling teams to focus on strategic decisions that drive development impact
- Gain insight into common pitfalls and a framework to assess ROI and feasibility of new technologies in your specific MIDD environment
- Share insights, ask questions and benchmark your organizations approach
12:00 pm Lunch Break & Networking
Workshop B
1:00 pm Regulatory Readiness: Mastering the M15 Blueprint to Strengthen Submissions & Accelerate Approvals
Synopsis
With the draft ICH M15 guidance set to formalize how modeling data is communicated in regulatory submissions, many leaders are asking: What does this look like in practice? While global agencies have signaled support for MIDD, translating that support into submission-ready content remains a challenge for most teams.
This workshop is not about high-level regulatory vision – it’s about operational readiness. Engage in discussions to learn the specific building blocks of a successful submission that incorporates MIDD under the ICH M15 guidelines, helping you lead teams, align internal stakeholders and communicate with regulators effectively.
Join this workshop to:
- Review real-world templates and examples of model summaries to best inform how to structure your own MIDD content for regulatory submission
- Hear guidance on what to include, what to leave out, how to internally align, and how to explain complex outputs clearly, helping you avoid delays and misinterpretations in MIDD submissions
- Leave with a checklist of actionable steps to assess your organization’s submission readiness