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Two Topic Imaging Workshop:
Day One - Standards for Imaging Endpoints in Clinical Trials
Day Two - Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products
Workshop Objectives:
- Develop consensus on the following key issues regarding imaging standards in clinical trials:
- Image Acquisition: quality control concepts, equipment, phantoms
- Image Interpretation: local vs. central read design, sources and solutions to read variability
- Data Management: display, storage, transmission
- Obtain feedback from:
- Pharmaceutical and medical device industries
- Contract research organizations—imaging core laboratories, academia, government agencies, and other professional and scientific organizations— toward developing the aforementioned standards for the use of imaging to determine endpoints in clinical trials and to inform regulatory guidance development
- Share regulatory perspectives on current Good Manufacturing Practices (cGMP) for PET imaging: review of the 21 CFR Part 212 cGMP regulation and the associated guidance
- Share lessons learned and expectations for Chemistry, Manufacturing and Controls (CMC) in regulatory submissions
- Share regulatory perspectives on PET radiopharmaceuticals registration and use in multicenter clinical trials
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