SNMMI Hosts FDA Workshop

February 18, 2020

On Friday, February 21, SNMMI and the Food and Drug Administration (FDA), Medical Imaging Technology Alliance (MITA), and World Molecular Imaging Society (WMIS) will be hosting a workshop entitled "PET Drugs: A Workshop on Inspections Management and Regulatory Issues."

The purpose of this workshop is to provide a forum for the exchange of information and perspectives on the regulatory and compliance framework for Positron Emission Tomography (PET) drug manufacturing. Bringing all stakeholders together will improve the global understanding of regulatory and compliance topics associated with PET drug manufacturing.

Registration

Click Here to register for this complimentary webcast. 
Please complete your registration by February 20, 2020.


View the Workshop Agenda
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Goals and Objectives

  • Discuss regulatory compliance for the development and manufacturing of PET drugs and pathways for drug applications, application maintenance, and inspections based on Part 212.
  • Share perspectives from industry, academia, investigators and regulators on inspectional findings and trends.
  • Provide information on the management of Part 212 inspections and maintenance of PET New Drug Applications and Abbreviated New Drug Applications.

Topics for Discussion

  • Trends on Inspections and Compliance
  • Life Cycle Management of PET Drug Applications
  • Product Quality Assurance
  • Changing Landscape of PET Drugs: Labeling, Electronic Submissions

*Agenda subject to change.