The GMP guidelines provide minimum requirements that a manufacturer of radiopharmaceuticals must meet to assure that their products are consistently high in quality, from batch to batch, for clinical use.
The Basics of cGMP is a 2 days on-site ESMIT course, providing guidance through EU-cGMP regulation for manufacturing, testing, and quality assurance of radiopharmaceuticals in order to ensure that a manufactured product is safe for human use. Principles regarding facilities, equipment qualification, controlled environmental conditions, processes and methods validation, standard operation procedures and user specific requirement, risk assessment, and specifications will be detailed. Also, the main components of investigational new drug and marketing authorisation dossiers will be discussed.
The registration is closed. Please contact us at esmit@eanm.org if you still want to register.
General knowledge regarding GMP and cGMP for Radiopharmaceuticals principles and guidelines.
Radiopharmacists and radiochemists in translational research, hospital radiopharmacy and radiopharmaceutical production centres.
Bucharest, Romania
Groningen, Netherlands
Coimbra, Portugal
Course Fee € 950.-
Registration Fee includes:
Registration Fee does NOT include:
Registration fees need to be paid 1 week prior to the event. In case the payment is not received by this deadline, the registration needs to be cancelled. Payment can be settled by Credit Card Cheques will not be accepted
Cancellations must be notified in writing to the EANM Office. Telephone cancellations cannot be accepted. Substitutions will be accepted if the name and e-mail address of the substitute are sent to the EANM Office 4 weeks prior to the event. In the case of cancellation 4 weeks before the course, we will refund you the fee less a € 100,- administration charge. After this date, we cannot grant any refund for cancellations. Any refund will take place after the respective course. EANM will not be held liable for cancellation fees of hotels, airlines or other means of transportation.
European School of Multimodality Imaging & Therapy (ESMIT)
Schmalzhofgasse 26
1060 Vienna
Austria
phone +43 1 890 44 27
e-mail esmit@eanm.org
