Level 3: High End Courses of EANM

14-15 de noviembre de 2019, Viena, Austria

Course content

The course focuses from the basics and fundamentals of Good Manufacturing Practice (GMP) through User Requirement Specification (URS), Validation, Deviations and Facility Planning. Moreover Radiation Safety, the question how to build up and manage a quality risk management system will be covered in the course.
Additionally it explains the increasing regulatory demands from laboratory work to clinical trials, going from laboratory notes to an Investigational Medicines Product Dossier (IMPD)

Learning Objectives

  • Fundamentals of GMP
  • Consequences of GMP Related Actions
  • The Needs and Demands to get a Radiopharmaceutical into a Clinical Trial
  • Points of Consideration when Planning a Radiopharmaceutical Facility
  • Quality Risk Management

Más información

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