Workshop A – Defining a Strategic Roadmap for Transitioning from Successful Clinical Trials to Regulatory Approval: Phase Appropriate Regulatory Strategy
Time: 8:30 am
day: Workshop Track 1
Details:
With regulatory approval and commercialization pivotal milestones in the microbiome drug development journey, join this workshop to benchmark best practices and engage in discussions to address:
- Designing a Phase-Appropriate Regulatory Strategy: Explore the strategic roadmap for transitioning from successful clinical trials to regulatory approval, focusing on key considerations at each stage of drug development
- Regulatory Challenges and Performance Control: Delve into the challenges of regulatory submissions and learn how to best control performance through robust planning, data analysis, and adherence to regulatory standards
- Establishing Reference Standards: Discuss the importance of reference standards and controls in ensuring accuracy in regulatory submissions, and explore practical approaches to implement them effectively
Participate in this collaborative workshop to develop a comprehensive strategic roadmap guiding you through the intricacies of the regulatory landscape. This roadmap aims to facilitate a smooth transition from successful clinical trials to regulatory approval and subsequent commercialization of your microbiome drug development program.
