Want a Say in the Development of Standards for Regenerative Medicine Therapies?
The 21st Century Cures Act emphasizes the importance of standards to the regenerative medicine field and the development of standards will continue to ramp up as the field matures. The regenerative medicine community needs a means of developing smart standards that are representative of the entire community's needs and are informed by experts across the regenerative medicine community. The resulting standards will yield the greatest benefits to the field as a whole.
In September 2017, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to Nexight Group and SCB to engage with experts to recommend processes and criteria to identify, prioritize, and assess the feasibility of potential standards for regenerative medicine therapies. Your input will shape these recommendations to help coordinate and effectively engage experts to advance potential standards.
During this workshop participants will:
- Validate and refine potential improvements to the coordination and engagement of the regenerative medicine community for standards needs identification, potential standards prioritization, and advancing potential standards to SDOs.
- Discuss the best means to engage community expertise from identification of needs or gaps in standards through publication of standards, best practices, or guidelines.
Please join us to share your thoughts and experiences and improve the way in which standards needs advance to ultimately contribute to the quality and safety of regenerative medicine products.