Regulatory Corner


The SRS provides the below links as a resource to members who would like to learn more about clinical regulatory requirements. However, providing these links should not be interpreted as complete endorsement of stated recommendations and procedures.

Asia

Japanese Guidenes for PET Clinical Research - in includes:
1. Guideline for production of PET RP (JSNM cGMP for PET Drugs) 
2. Guideline for preclinical tests for PET RP 
3. Guideline for clinical trial for PET RP.
~ Unfortunately, there is no English version of this document.

Europe

From the European Association of Nuclear Medicine's Radiopharmaceutical Commitee

United States

1. FDA CGMP for PET Rule
2. FDA Guidance document
3. USP General Chapter <823>
4. CMC Postapproval Manufacturing Changes To Be Documented
5. FDA Oversight of PET Drug Products - Q&A
6. IND Applications for PET Drugs
7. Sterile Drug Products via Aseptic Processing - CGMP

If you would like to recommend documents and links to add to the Regulatory Corner, please provide your suggestion(s) through the Contact page.

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Currently, the member-only content is limited to presentations from past meetings and "Regulatory Corner" guidance documents. For your convenince, we've also included links to other information which are available on the public "Links" page, too.

Selected Presentations from Past Meetings

From Various Presymposium Workshops at ISRS 2015

[18F]fluoride and nucleophilic aromatic substitutions
Johannes Ermert, PhD

[18F]Fluoride and Nucleophilic Aliphatic Substitution
Andrews Katsifis, PhD

Molecular Imaging of Cancer
Jonathan McConathy, PhD

What’s Involved in Translating Radiopharmaceuticals for Human Use in the US?
Sally Schwarz, RPh

Canonical and Atypical C-11 Radiochemistry Applications for Human Imaging
Neil Vasdev, PhD

Successes and pitfalls in tracer development: Lessons learned from neuroinflammation, Bert Windhorst, PhD

Macromolecules and their labeling with fluorine-18
Frank Wuest, PhD

Radiolabeled peptides - Radiopharmacology
Frank Wuest, PhD

From the Pre-Symposium Workshop on the Production of Radiopharmaceuticals for Clinical and Research Uses at ISRS 2013

The European Perspective
Philip Elsinga, PhD, UMC Groningen, The Netherlands

The Asian Perspective (Japan and Korea)
Yasuhisa Fujibayashi, PhD, D.Med.Sci., National Institute of Radiological Sciences, Chiba, Japan

The U.S. Perspective
Sally W. Schwarz, MS, BCNP, Washington University at St. Louis, MO USA

Presentations from symposia prior to ISRS 2013

Targeted Imaging: the right radiolabeled probe for the right target for the right disease
William C. Eckelman, PhD

Graduate Training in Imaging Sciences at Washington University
Carolyn J. Anderson and Michael J. Welch

Filling the “Isotope Specialist” Pipeline: The Washington State University Approach
Ken Nash, et. al.

Reversing The Trend: Radiochemistry at the University of Missouri-Columbia
J. David Robertson, et. al.

Is there a Crisis in Nuclear and Radiochemistry Education in the U.S.?
Heino Nitsche

Member Access to NMB Online

View NMB online access instructions.

Radiopharmaceutical Databases

Radiosynthesis Database of PET Probes (RaDaP) is an online database for radiosynthesis of PET probes, published in peer-reviewed scientific journals. Learn more

The Molecular Imaging and Contrast Agent Database (MICAD) is an online source of information on in vivo molecular imaging agents based on recommendations from the extramural community. Learn more