Manufacturing PET Radiopharmaceuticals

Special Workshop organized by CMOD in collaboration with SNM

May 1, 2009


Introduction and Overview - Peter Libby, Brigham and Women’s Hospital; Donald M. Black, GEHC Diagnostics; Michael M. Graham, U of Iowa

PET Drug Regulation: A Brief History - Dennis Swanson, University of Pittsburgh

Review of Current USP Chapter 823 for IND and RDRC Regulated PET Compounding - Sally Schwarz, Washington University

Current Regulatory Draft Guidelines for PET Drug  Products - Eldon Leutzinger, Chemistry Team Leader, Medical Imaging,  FDA

Applying Current Guidelines: Challenges and Successes - Luke Augustine, PharmD, Cardinal Health

CGMP Compliance with a Centralized IND – Comparison of FDA PET CGMP and USP <823> Requirements - Joseph Hung, Mayo Clinic

The Development and Commercialization of New PET Tracers - Donald Black, Head R&D GEHC Diagnostics

Introduction to the SNM Clinical Trials Network: CMC Compliance  with a Multicenter IND - George Q. Mills, Perceptive Informatics

Q & A and Guided Panel Discussion