Topics for Discussion

  • Overview of Regulatory Process for Marketing and Licensing of Radiopharmaceutical Devices
  • Novel Radiopharmaceuticals: physical standards development, product quality considerations, supply and demand
  • Safety and Efficacy Considerations for Radiopharmaceutical Products
  • The Evolving Landscape—Radiological Devices
  • Clinical Trial Design Considerations for Radiopharmaceuticals

Questions be submitted to Lisa Dimmick at [email protected]

WebEx Registration

The October 14th workshop will be conducted using Cisco WebEx.  To participate in the workshop, please pre-register by October 9, 2020 at https://usnrc.webex.com/usnrc/onstage/g.php?MTID=eabeba69a55ff5fc6faf8d90db0b2e450.

To test your ability to connect to a WebEx meeting, visit https://www.webex.com/test-meeting.html.  Please contact your IT department if the test fails.  For tips on how to optimize your WebEx experience, see Cisco’s “Best Practices for Online Meetings”.

Webcast Information

In addition to WebEx, a live webcast of the workshop WebEx will be available at https://video.nrc.gov/.

Meeting Materials

Agenda (PDF – 122KB)

Contact

For additional details, contact

Technical Contacts:
Frank Lutterodt, Project Manager, DIRM,
FDA [email protected]
Lisa Dimmick, Team Leader, Medical Radiation Safety,
U.S.NRC [email protected]
Meeting Logistics: Sarah Lopas [email protected]