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Bringing Therapy Radioisotopes into Clinical Radiopharmacy – Some Regulatory Aspects

June 11 09:00 June 12 12:30 CEST

Bringing Therapy Radioisotopes into Clinical Radiopharmacy” is an advanced course designed to bridge the gap between isotope production, radiopharmaceutical preparation and clinical application. This course focuses on the practical and regulatory hurdles of integrating therapeutic radionuclides into hospital settings.

Diving into production and purification methods of emerging therapeutic isotopes, supply chain and matched pairs for theranostics, we’ll then navigate the regulatory landscape (cGMP, marketing authorizations, and clinical trials). Understanding how the radiometals and radiohalogens used in therapy are used for radiopharmaceutical preparation correlates with quality control standards specific to alpha and beta emitters.

We will focus on transitioning from a research lab to a clinical radiopharmacy, revising documentation requirements and facility design for high-energy beta and alpha particles, and also safety protocols for pharmacists, radiochemists and technicians.

This course provides the blueprint for establishing a modern, therapy-ready radiopharmacy, moving beyond diagnostic imaging into the era of personalized molecular radiotherapy.

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Learning Objectives

General knowledge regarding GMP and cGMP for Radiopharmaceuticals principles and guidelines.

Target Audience

Hospital and production radiopharmacists, and radiochemists involved in clinical trials with radiopharmaceuticals, hospital radiopharmacy and radiopharmaceutical production.

Faculty

Dana Niculae

Speaker

Bucharest, Romania

Neil Hartman

Speaker

Swansea Bay, UK

Antero Abrunhosa

Speaker

Coimbra, Portugal

Registration Details

Course Fee               € 950.-

NEW Department Package: If you send 5 participants from your department, you will get an additional 6th seat for free for this course. Please get in touch with the ESMIT office if this is of interest to you.

Registration Fee includes:

  • Electronic Course Book, including all Slides
  • Coffee & Lunch Breaks

Registration Fee does NOT include:

  • Travel to the Venue
  • Accommodation

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.

ESMIT

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Future Health Lab

Alfred-Adler-Straße 1
Vienna, 1100 Austria
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