ARMI | BioFabUSA and the Standards Coordinating Body (SCB) with Nexight Group have partnered for a workshop, which will precede the BioFabUSA Spring Summit on Tuesday, June 5 from 6:00-9:00 PM.
Standards development for regenerative medicine therapies is being encouraged by the 21st Century Cures Act and will continue to ramp up as the field matures. The regenerative medicine community needs a process in place to develop standards that are representative of the entire community’s needs and will, as a result, yield the most positive improvements to the field as a whole.
In September 2017, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to the 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: (1) 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; and (2), Inform and discuss potential criteria used during the standards identification, prioritization, and feasibility assessment process.
Please RSVP for the workshop by contacting Allison Getz at SCB at email@example.com before Tuesday May 22nd to share your thoughts and experiences as well as improve the way in which standards needs advance to ultimately contribute to the quality and safety of regenerative medicine products.