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Interactive Course on First-In-Human Studies

Level 3: High End Courses

Information and registration: here

COURSE CONTENT

This course covers fundamentals of the translation of a preclinical PET radioligand/radiotracer to a clinically applicable PET radiopharmaceutical. This includes lectures and interactive discussions on tracer design and synthesis, preclinical evaluation, target validation, the value of animal models, particular requirements of in CNS and cancer related applications, as well regulatory requirements (e.g. IMPD, dosimetry, toxicity) according to European Legislation.


LEARNING OBJECTIVES

  • improve knowledge and understanding of the general procedure in translation a radiopharmaceutical into clinical application
  • understand how a new radiopharmaceutical is designed, synthesized and preclinically tested
  • get to know on the similarities and differences in radiopharmaceuticals for oncologic and neurologic purposes
  • learn planning, performing and analysing preclinical studies
  • understand the capabilities & limitations of animal models
  • acquire practically applicable knowledge on the procedures for regulatory requirements
  • establish understanding on the need to move forward with the radiopharmaceutical after the initial first-in-human study
  • become a valuable partner for basic scientists, clinicians and industry in planning and performing first-in-human PET studies

TARGET AUDIENCE

The target audience includes biologists, chemists/radiochemists, and radiopharmacists as well as Nuclear Medicine physicians with the interest to improve the translation of new radiopharmaceuticals to clinical application, to develop new radiopharmaceuticals according to clinical requirements, and to increase the utilization of the radiopharmaceutical development process.