RDRC Membership: SNM Suggestions Mathew L. Thakur, Ph.D. President Society of Nuclear Medicine.

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Presentation transcript:

RDRC Membership: SNM Suggestions Mathew L. Thakur, Ph.D. President Society of Nuclear Medicine

RDRC Membership: SNM Suggestions Background –The Society of Nuclear Medicine is an international scientific and professional organization founded in –SNM’s mission is to promote the science, technology and practical application of nuclear medicine. –The Society’s 15,000+ members are physicians, technologists, and scientists specializing in the research and practice of nuclear medicine.

RDRC Membership: SNM Suggestions Background (cont) –In addition to publishing journals, newsletters and books, SNM also sponsors international meetings and workshops designed to increase the competencies of nuclear medicine practitioners and to promote new advances in the science of nuclear medicine.

RDRC Membership: SNM Suggestions FDA and RDRCs –The Society is a long-standing supporter of RDRCs, and their contributions to both nuclear medicine practitioners and the patients they serve. –SNM welcomes all opportunities to work more closely with FDA staff to enhance the effectiveness of RDRCs.

RDRC Membership: SNM Suggestions FDA and RDRCs –SNM believes that RDRCs benefit greatly from current 21 CFR 361.1(c) 1 requirements that RDRCs be minimally comprised of – A nuclear medicine physician A person qualified to formulate radioactive drugs A person with special competency in radiation safety and radiation dosimetry.

RDRC Membership: SNM Suggestions FDA and RDRCs –The SNM believes that RDRCs would benefit further in their activities and effectiveness by including a Pharmacologist in their composition. SNM’s rationale for this suggestion is that a Pharmacologist could better advise RDRCs on specific toxicity issues of specific radiopharmaceuticals.

RDRC Membership: SNM Suggestions FDA and RDRCs –With respect to potential changes in how FDA staff review qualifications of new members being added to an RDRC, SNM suggests the following procedure: –RDRC submits to FDA staff the qualifications (CV) of the RDRC’s suggested new member and their prospective role in the RDRC

RDRC Membership: SNM Suggestions FDA and RDRCs –FDA staff review the qualifications of the proposed new RDRC member within 30 days of receipt of the individual’s paperwork, and make any recommendations regarding the individual back to the RDRC within the 30 day period. –The RDRC reviews any FDA staff recommendations regarding the new RDRC member and takes such recommendations into account during their final decision- making process on the new RDRC member.