Optical Surgical Navigation (OSN) Workshop: Discovery to Clinical Acceptance Part 2

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About Course

The Optical Surgical Navigation workshop will highlight experts from various institutions to discuss ongoing clinical trials and developments in the field of intraoperative molecular imaging. This workshop will focus on clinical trial design considerations and advancing regulatory guidance.  The second session of this workshop is facilitated by representatives from the US Food and Drug Administration (FDA). The FDA experts will lead discussions aimed at providing invaluable insights into regulatory pathways, fostering a deeper understanding of essential considerations in clinical trial design, and addressing pertinent queries regarding the support required from the FDA for clinical translation.

By the conclusion of the workshop sessions, participants will be updated on the progress of new research and the progress of clinical trials and will gain a deeper understanding of regulatory requirements, clinical trial design principles, and the critical role of FDA support in facilitating the development and commercialization of surgical navigation technologies. Armed with newfound insights and guidance, participants will be better equipped to navigate regulatory pathways and design robust clinical trials.

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Course Content

Introductory FDA Remarks

  • Introductory FDA Remarks
    00:00

Device Development and Evaluation

Quality Considerations for Optical Imaging Drugs

Nonclinical Safety Assessments for Optical Imaging Drugs

Clinical Trial Design and Analysis: Clinical Considerations

Novel Design and Methodology in View of Clinical Reality in Optical Imaging Drug Development