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Clinical Trials Network Mid-Winter Meeting Workshop 2011 - PET Manufacturing Regulations and Implementation - Part II
Clinical Trials Network Mid-Winter Meeting Workshop 2011 - PET Manufacturing Regulations and Implementation - Part II
Clinical Trials Network Mid-Winter Meeting Workshop 2011 - PET Manufacturing Regulations and Implementation - Part II


Authors

David W. Dick, PhD, has nothing to disclose.

Steven S. Zigler, PhD, is employed by PETNET Solutions.

Ken Phelps, BS, has nothing to disclose.

Target Audience
Physicians, pharmacists, and technologists.

Objectives
At the completion of this activity, the participant will be able to:
1. Discuss the current FDA status on Part 212 regulations and the recent changes in PET manufacturing.
2. Describe how manufacturers and imaging sites can best prepare for an FDA inspection/audit.
3. Discuss how to navigate the FDA electronic submission process for research PET drugs.

Continuing Education Credit Information

AMA-PRA (Physician)
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 3.75 AMA PRA Category 1 CreditTM. Physicians should claim only credit commensurate with the extent of their participation in the activity. To receive CE credit, learners must achieve a score of 80% on the post-course assessment and complete the evaluation. Release date: 10/12/12 Expiration date: 10/12/15.

   

ACPE (Pharmacists)

SNMMI is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity has been designated as knowledge-based CPE. The universal program number for this enduring material is 0210-0000-12-391-H04-P. Total available credit for pharmacists is 3.75 hours or 0.375 CEUs. Release date: 10/12/12 Expiration date: 10/12/15. To receive CE credit, learners must achieve a score of 80% on the post-course assessment and complete the evaluation.

VOICE (Technologists)
The SNMMI, through its Verification of Involvement in Continuing Education (VOICE) program, has approved this journal article for a maximum of 2.75 continuing education hours (CEHs). VOICE-approved credit is recognized by most licensure states and by the NMTCB and ARRT as Category A credit. In order to receive CE credit, you must first complete the activity content. When completed, take the post-test assessment.  You must obtain a score of 80% to receive the CE credit.  You will have no more than 3 attempts to successfully complete the post-test. Release date: 10/12/12 Expiration date: 10/12/15. California Scope: 2.75 Imaging(I)/Non-Imaging(NI) / Radiopharmacy(R) / Therapy(T).

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