Souvik Bhattacharya
Seminars
In this interactive session, join focused roundtables discussions tailored to key therapeutic areas including Oncology, CNS and Immunology & Inflammation.
Each table will provide an opportunity for in-depth conversation around the unique challenges within these areas. Share experiences, explore innovative approaches and gain practical insights to help improve and streamline development timelines in your specific field.
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
