Realizing the Benefit of 21st Century Cures through Standards Development: A Workshop Convened by FDA, NIST, SCB, and Nexight Group
Dates: March 18 - 19, 2019
National Cybersecurity Center of Excellence (NCCoE) in Rockville, MD
WORKSHOP OBJECTIVES:
Increase participation in the standards development process
Promote use of standards in product development and regulatory approval
Increase awareness of the reference material development process
Target Audience:
This workshop is intended for individuals from the regenerative medicine community who can drive the development and adoption of standards based on their role within their organization. These individuals should be strongly focused on improving the quality and safety of regenerative medicine products throughout the product development process, including research and development, manufacturing, and clinical translation. Targeted stakeholders include:
Product manufacturers
Academic institutions
Raw material providers
Logistics delivery providers
Clinical trial sponsors
At the workshop, representatives from Standards Developing Organizations (SDOs) and industry organizations that actively support standards advancement will provide information on recent efforts that highlight the benefits of standards and of participating in the standards development process. Participants will also learn about current regenerative medicine standards efforts that need community support and participate in discussions to support their advancement.
AGENDA: View the agenda for the workshop
PRESENTER BIOS: View the bios of the speakers and presenters
REGISTRATION: Registration has reached maximum capacity and is currently closed.
TRAVEL INFORMATION AND SECURITY PROCEDURES:
Please view the NCCoE Visitor Guide for a list of nearby airports, hotels, and restaurants as well as directions to the facility.
A government issued form of ID (agency badge, driver’s license, passport, state id, etc.) must be provided to the security officer to gain access to the building. All NIST and MITRE employees are required to show employee badges.
International visitors must be processed through the NIST visitor registration system prior to the attending the workshop. Please contact Allison Getz (agetz@regenmedscb.org) to complete the required registration form.
If you have any additional questions about the workshop, please contact SCB directly.