JNM CE/SAM (February 2019): Harmonization of U.S., European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible?

JNM, January 2019, Volume 60, Number 2

Release Date: 2/1/2019
Expiration Date: 1/28/2022

SNMMI Members: Free
Non-Members: $69.00

Continuing Education Credit Information

ABNM SAM Credit
The American Board of Nuclear Medicine has reviewed and approved this Journal SAM activity submitted by the SNMMI. This activity fulfills the requirements of the ABNM Maintenance of Certification program for self-assessment. 2.0 SAMs have been awarded for this activity.

AMA-PRA (Physician)
The Society for Nuclear Medicine and Medical Imaging, Inc. (SNMMI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. SNMMI designates this enduring material for a maximum of 2.0 AMA PRA Category 1 CreditsTM. Physicians should claim only credit commensurate with the extent of their participation in the activity.

Objectives
On successful completion of this activity, participants should be able to...
1. List the requirements for first-in-human radiopharmaceuticals applications for the United States, European Union, and Canada.
2. Realize the overall need for reduction of the human-use requirements due to lack of toxicity and the need to facilitate patient access.
3. Recognize that harmonization efforts between the U.S. Food and Drug Administration, Health Canada, and the European Medical Authority would streamline efforts in moving new radiopharmaceuticals forward for clinical care.


Target Audience
This article contains information of value to nuclear medicine physicians and scientists.

Authors
Sally W. Schwarz1, Clemens Decristoforo2, Anne E. Goodbody3, Nikhita Singhal4, Sarah Saliba4, Patrick S. Ruddock3, Katherine Zukotynski4, and Andrew A. Ross5

1Washington University School of Medicine, St. Louis Missouri; 2Department of Nuclear Medicine, Medical University Insbruck, Innsbruck, Austria; 3Center for Probe Development and Commercialization, Hamilton, Ontario, Canada; 4McMaster University, Hamilton, Ontario, Canada; and 5Department of Diagnostic Imaging, Queen Elizabeth Health Sciences Center, Halifax, Nova Scotia


Disclosure
Dr. Schwarz is an SNMMI past president, a consultant/advisor for Schwarz Consulting, and an employee of Washington University School of Medicine. In accordance with ACCME Revised Standards for Commercial Support and SNMMI Conflict-of-Interest Policy, the authors have indicated no other relevant relationships that could be perceived as a real or apparent conflict of interest. Disclosure of a relationship is not intended to suggest or to condone bias but is made to provide participants with information that might be of potential importance to their evaluation of the activity.

Contact Information
For questions please contact Lisa Dickinson, Associate Director of Education at ldickinson@snmmi.org or 703-652-6783.