CME 1 Session – EANM’12

(1)

Status of Good Radiopharmaceutical Practice (GRPP)

Educational objectives:

  1. To have an overview of new legislation developments for cGRPP
  2. To learn the necessary basic requirements for a radiopharmaceutical for clinical studies
  3. To show the possibilities and limits of a cGRPP facility considering the academic requests

Summary:
This continuing education session is directed primarily towards radiochemists, radiopharmacists and nuclear medicine physicians, who are interested to perform clinical studies with radiopharmaceuticals in an academic institute. The production of radiopharmaceuticals under GMP changed in the last decade and the legal requirements improved. The current good radiopharmacy practice (cGRPP) guideline was development by the EANM committees to take into account the special demands of radiopharmaceuticals under GMP production. This CME will give an update on new legal developments in respect to the cGRPP guideline. Furthermore the demands, the problems and possible solutions for the cGRPP production of radiopharmaceuticals for clinical trials will be discussed. The third talk presents the possibilities to combine the expectations of an academic institution with the cGRPP requirements.

The CME will give an overview of the actual legislation developments for the production of radiopharmaceuticals under cGRPP with a focus on aspects related to academic institutions.

Key Words:
GMP, Radiopharmacy, GRPP, Clinical Trials, Legislation

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