Realizing the Benefit of 21st Century Cures through Standards Development: A Workshop Convened by FDA, NIST, SCB, and Nexight Group

Monday, January 14, 2019, 8:30 AM - Tuesday, January 15, 4:00 PM at the National Cybersecurity Center of Excellence (NCCoE) in Rockville, MD.


WORKSHOP DESCRIPTION:

This workshop will feature updates from Standards Development Organization (SDO) representatives and industry organizations on the benefits of standards and of participating in the standards development processes. Participants will also have the opportunity to learn about current regenerative medicine standards efforts that need community support and participate in discussions to support their advancement.

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: RM manufacturers, clinical trial sponsors, contract manufacturers, academic institutions, raw material providers, and logistics delivery providers.

AGENDA: Please click here to view the draft agenda.

REGISTRATION:

To allow for engaging and effective round table discussions, attendance will be limited to 100 people. We request registering no more than two participants per organization, please. If registration has reached maximum capacity, you will be added to the waiting list.

General registration will open Monday, December 10, 2018.

STUDENT TRAVEL AWARDS:

SCB is pleased to offer support of up to $1,000 in travel reimbursement to graduate students interested in attending this workshop. Students enrolled in a graduate program in biology, biomedical engineering, regenerative medicine, translational medicine or a related field are encouraged to apply. Travel award applications can be found here and must be submitted to Kelly Sauerwein at ksauerwein@regenmedscb.org by December 14, 2018 in order to be considered. Travel grant recipients will be notified via email on or before December 20, 2018.

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.