Regulatory Readiness: Mastering the M15 Blueprint to Strengthen Submissions & Accelerate Approvals
Time: 1:00 pm
day: Pre-Conf Workshop Day
Details:
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
